MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-05-18 for MODIFIED TRINKLE REDUCTION DRIVE UNIT 532.020 manufactured by Synthes Oberdorf.
[20147355]
It was reported that the trinkle reduction drive device did not work when attached to the drill device. The event was not reported to have occurred during surgery. It was not reported if there were any delays in a surgical procedure or if a spare device was available. There were no reports of injuries, medical intervention or prolonged hospitalization. The date of event was unknown. Several attempts have been made to obtain additional information concerning the reported event; however, no additional information has been provided. A supplemental medwatch report will be submitted if further information is received.
Patient Sequence No: 1, Text Type: D, B5
[20528330]
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. 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
[24242842]
The actual device was returned for evaluation. Reliability engineering evaluated the device and observed that the device was frozen and the locking ring was loose. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to due to wear on components from repeated sterilization and use over time. 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 | 8030965-2015-10910 |
| MDR Report Key | 4779643 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-05-18 |
| Date of Report | 2015-04-22 |
| Date Mfgr Received | 2015-07-24 |
| Device Manufacturer Date | 2004-11-16 |
| Date Added to Maude | 2015-06-17 |
| 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 | 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 | MODIFIED TRINKLE REDUCTION DRIVE UNIT |
| Generic Name | DRIVER, SURGICAL, PIN |
| Product Code | GFC |
| Date Received | 2015-05-18 |
| Returned To Mfg | 2015-04-24 |
| Catalog Number | 532.020 |
| 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 | SYNTHES OBERDORF |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF CH4436 SZ CH4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-18 |