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 2017-01-04 for TRINKLE QUICK-COUPL MODIFI F/532.001 532 532.020 manufactured by Depuy Synthes Power Tools.
[63867179]
(b)(4). (b)(6). The actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition was confirmed. The assignable root cause was determined to be due to device wear from normal use and servicing. If additional information should become available, a supplemental medwatch report will be sent accordingly.
Patient Sequence No: 1, Text Type: N, H10
[63867180]
It was reported from (b)(6) that the quick coupling device reverse rotation was not smooth. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of this 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
| Report Number | 8030965-2017-10038 |
| MDR Report Key | 6222865 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-04 |
| Date of Report | 2016-12-12 |
| Date Mfgr Received | 2016-12-12 |
| Device Manufacturer Date | 2012-10-31 |
| Date Added to Maude | 2017-01-04 |
| 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 | 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 QUICK-COUPL MODIFI F/532.001 532 |
| Generic Name | DRIVER, SURGICAL, PIN |
| Product Code | GFC |
| Date Received | 2017-01-04 |
| Returned To Mfg | 2016-12-13 |
| Catalog Number | 532.020 |
| Lot Number | MA1052 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-01-04 |