MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-06-26 for TRINKLE REDUCTION DRIVE UNIT 532.019 manufactured by Depuy Synthes Products Llc.
[112550678]
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If additional information should become available, a supplemental medwatch report will be sent accordingly.
Patient Sequence No: 1, Text Type: N, H10
[112550679]
It was reported that during service and repair pre-testing, it was observed that the ball inside the coupling piece on the reduction drive device came out. It was further determined that the device failed steps 80 - 100. This event did not occur during 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
| Report Number | 8030965-2018-54646 |
| MDR Report Key | 7639167 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-12 |
| Date of Event | 2018-06-12 |
| Date Mfgr Received | 2018-07-26 |
| Device Manufacturer Date | 2008-03-13 |
| Date Added to Maude | 2018-06-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SYNTHES PRODUKTIONS GMBH |
| Manufacturer Street | HAUPTSTRASSE 24 |
| Manufacturer City | WALDENBURG 4437 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4437 |
| 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 | 2018-06-26 |
| Returned To Mfg | 2018-04-03 |
| Catalog Number | 532.019 |
| 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 PRODUCTS LLC |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-26 |