MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-02-19 for TRINKLE REDUCTION DRIVE UNIT 532.019 manufactured by Synthes Oberdorf.
[5361057]
It was reported that the trinkle reduction drive device fell apart. The event was not reported to have occurred during surgery. It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use. There were no reports of injuries, medical intervention or prolonged hospitalization. The reporter stated that the event occurred on january 2015; however, 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
[12829609]
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
[22995977]
The actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition was confirmed. It was determined that the device appeared to have been mishandled or dropped. The assignable root cause was determined to be due to mishandling. 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 | 8030965-2015-10236 |
| MDR Report Key | 4527171 |
| Report Source | 06 |
| Date Received | 2015-02-19 |
| Date of Report | 2015-01-22 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-03-02 |
| Device Manufacturer Date | 2006-02-13 |
| Date Added to Maude | 2015-03-25 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 2015-02-19 |
| Returned To Mfg | 2015-01-27 |
| Catalog Number | 532.019 |
| Lot Number | MA1006 |
| 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 | 2015-02-19 |