MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-22 for TRINKLE REDUCTION DRIVE UNIT 532.019 manufactured by Synthes Oberdorf.
[41171735]
The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. Reliability engineering evaluated the device and the reported condition was confirmed. The assignable root cause was determined to be due to a faulty material. If additional information should become available, a supplemental medwatch report will be sent accordingly.
Patient Sequence No: 1, Text Type: N, H10
[41171736]
It was reported that during service and repair, it was observed that the trinkle reduction drive device was found with a broken, torn off coupling tool side. This event was not related to surgery. There was no patient involvement. 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
[41174640]
Result and conclusion codes were incorrectly assigned in the initial report. The result and conclusion codes were corrected to accurately reflect the evaluation results and conclusion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2016-11833 |
| MDR Report Key | 5517154 |
| Date Received | 2016-03-22 |
| Date of Report | 2013-11-19 |
| Date of Event | 2013-11-19 |
| Date Mfgr Received | 2016-03-24 |
| Date Added to Maude | 2016-03-22 |
| 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 |
| Reporter Occupation | SERVICE AND TESTING PERSONNEL |
| 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 | SYNTHES OBERDORF |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF CH4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4436 |
| 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 | 2016-03-22 |
| Returned To Mfg | 2013-11-19 |
| Catalog Number | 532.019 |
| 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 | SYNTHES OBERDORF |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF CH4436 SZ CH4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-22 |