DOUBLEAIRHOSE L5M F/SYST SYNTHES 519.530

[69021005] Additional narrative: (b)(4). The manufacturing location was unknown. The serial number was unknown. Therefore, device manufacture date is unknown as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10

[69021006] It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the hose of the double air hose device exploded. According to the reporter, when the surgery started, the hose was passed and connected to the wall of the institution. It was reported that at the time of the nail milling, the corresponding adapter was applied to the hose to verify that it was well and worked well. The reporter stated that when it was decided to pass the first reamer device, the first pistol was passed to the surgeon without triggering the device and the hose exploded. There was a sixty minute delay to the surgical procedure. It was not reported if a spare device was available for use. There was patient involvement reported. It was not reported if there were injuries or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5

[71027774] (b)(4). Device manufacture date: the device manufacture date is unavailable. During subsequent follow-up with the reporter, additional information was obtained. The reporter clarified that the event was intraoperative and the surgery was successfully completed. It was reported that the surgery was the second procedure because the implant that the patient had was from another company. According to the reporter, the adapter device did not present any malfunction at the time of the event. It was reported that the pistol that was mentioned in the initial report referred to the handpiece device. It was further reported that the reamer device and the handpiece device could not be used due to the hose explosion. Therefore, there was no allegation of malfunction against these devices. It was reported that there were no patient or user injuries or additional medical intervention required as a result of this event. There was no undesired treatment outcome. It was reported that the current status of the patient was good. According to the reporter, there was no visual damage to the device prior to use and there were no fragments generated. It was reported that no part of the device remained in the patient after surgery. The handpiece device and the adapter device have been included in the concomitant medical products section. Serial number: the device serial number was not provided by the reporter in the initial report. Therefore, the serial number was unknown. The serial number was identified as (b)(4). If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10

[96128745] The actual device has been returned and is currently pending evaluation. Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.
Patient Sequence No: 1, Text Type: N, H10

[115286559] (b)(4). Correction: device availability: the device availability was inadvertently documented as may 29, 2017 in the initial report. The date returned to manufacturer was corrected to jun 29, 2017. The manufacturer location was documented as unknown in the initial report. The location has been updated to (b)(4). Contact office name/address has been updated accordingly to reflect the corrected manufacturing facility. Device manufacture date: the device manufacture date was documented as unknown in the initial report. The device manufacture date has been updated as may 27, 2008. If information is obtained that was not available, a follow-up medwatch will be filed as appropriate. Device evaluation: the actual device was returned for evaluation. During repair, it was determined that the reported condition was confirmed. The coupling side of the device was disassembled and it was determined that the inner hose of the product (black hose) was damaged. Tests with the compressed air was performed and it was determined that the air hose was leaky at the coupling side. It was further determined that the press-sleeve (pressh? Lse) was not originally assembled (pressed) by the manufacturer. That meant the air hose had been already disassembled and the press-sleeve was replaced. It was further determined that the coupling tool side was not functioning and was defective. The assignable root cause was determined to be due to unauthorized repair, which is user error/misuse/abuse. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10