MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-02-01 for BLACKMAX-NEURO BLACKMAX-N_LL manufactured by Depuy Synthes Power Tools.
[66235456]
Udi: (b)(4). 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
[66235460]
It was reported that during an unspecified surgical procedure, it was observed that the motor device stopped working. There were no delays to the surgical procedure. A spare device was used to successfully complete the procedure. There was patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The reporter stated that the event occurred on either the (b)(6) 2016; however, the exact date of the event was unknown. 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
[67572024]
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. 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
[67681832]
Additional narrative: the actual device was returned for evaluation. Reliability engineering evaluated the device and observed that the device would not lock the mra cutter, the seal was protruding from the swivel the hose had no prv and the muffler tube was loose. It was also observed that the pawls were worn out preventing the mra cutter from locking. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to component damage caused by normal wear from use and servicing over time. 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
| Report Number | 1045834-2017-10292 |
| MDR Report Key | 6292344 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-02-01 |
| Date of Report | 2016-12-14 |
| Date of Event | 2016-12-01 |
| Date Mfgr Received | 2017-02-15 |
| Device Manufacturer Date | 2008-07-02 |
| Date Added to Maude | 2017-02-01 |
| 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 | RODNEY CRAIN |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5616271080 |
| Manufacturer G1 | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLACKMAX-NEURO |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC - HANDPIECE |
| Product Code | HSZ |
| Date Received | 2017-02-01 |
| Returned To Mfg | 2017-02-01 |
| Catalog Number | BLACKMAX-N_LL |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Address | 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-01 |