MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-03 for DOUBLEAIRHOSE L3M F/SYST-SYNTHES 519.510 manufactured by Umkirch.
[91453808]
(b)(4). Device manufacture date: the device manufacture date is unavailable. The manufacturing location is currently not available. The reporter? S phone number was not provided. 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. This medwatch is being resubmitted due to outage in fda's electronic submission gateway (esg) upon initial submission.
Patient Sequence No: 1, Text Type: N, H10
[91453809]
It was reported from (b)(6) that during a femur trochanteric fracture surgery, it was discovered that the double air hose device could not be detached from the compact air drive device. According to the reporter, in order to use compact air drive device, the surgeon tried to detach the connecting part of the double air hose device. However, the connecting part was stuck with the counterpart, so the surgeon could not remove the hose. It was reported that because the surgeon could not ream the medullary cavity, he inserted a nail which was not supposed to be the originally planned size. It was reported that the event occurred during use on a patient. There were no any delays to the surgical procedure. It was not reported if a spare device was available for use. There was patient involvement reported. There were no reports of injuries, medical intervention 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
| Report Number | 8030965-2017-15966 |
| MDR Report Key | 6999303 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-03 |
| Date of Report | 2017-10-18 |
| Date of Event | 2017-10-18 |
| Date Mfgr Received | 2017-11-09 |
| Device Manufacturer Date | 2011-09-21 |
| Date Added to Maude | 2017-11-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | UMKIRCH |
| Manufacturer Street | IM KIRCHENHURSTLE 4 |
| Manufacturer City | UMKIRCH B. FREIBURG D-79224 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-79224 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOUBLEAIRHOSE L3M F/SYST-SYNTHES |
| Generic Name | INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2017-11-03 |
| Returned To Mfg | 2017-11-09 |
| Catalog Number | 519.510 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UMKIRCH |
| Manufacturer Address | IM KIRCHENHURSTLE 4 UMKIRCH B. FREIBURG D-79224 GM D-79224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-03 |