MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-08 for TRINKLE REDUCTION DRIVE UNIT 532.019 manufactured by Depuy Synthes Power Tools.
[40077411]
Reporter? S phone number: (b)(6). 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
[40077412]
It was reported from (b)(6) that during an anterior cruciate ligament surgery, it was observed that the coupling shaft was broken on the reduction drive unit device. There was a six minute delay to the planned surgical procedure and a spare device was available for use. There was patient involvement reported. There were no reports of injuries, medical intervention, or prolonged hospitalization. The exact date of this event is not known. 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
[40965038]
The actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition was confirmed. It was further determined that the coupling shaft broke off the device and was in two pieces. The assignable root cause was due to improper handling. If additional information should become available, a supplemental medwatch report will be sent accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2016-11334 |
| MDR Report Key | 5485873 |
| Date Received | 2016-03-08 |
| Date of Report | 2016-02-05 |
| Date Mfgr Received | 2016-03-16 |
| Device Manufacturer Date | 2008-09-19 |
| Date Added to Maude | 2016-03-08 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Street | HAUPTSTRASSE 24 |
| Manufacturer City | WALDENBURG CH4437 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRINKLE REDUCTION DRIVE UNIT |
| Generic Name | DRIVER, SURGICAL, PIN |
| Product Code | GFC |
| Date Received | 2016-03-08 |
| Returned To Mfg | 2016-02-12 |
| Catalog Number | 532.019 |
| Lot Number | MA1010 |
| 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 | HAUPTSTRASSE 24 WALDENBURG CH4437 SZ CH4437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-08 |