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 2017-07-28 for MODIFIED TRINKLE REDUCTION DRIVE UNIT 532.020 manufactured by Depuy Synthes Power Tools.
[81242975]
(b)(4). (b)(6). 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
[81242976]
It was reported from (b)(6) that during a tibial nail insertion surgical procedure for a fractured tibia, it was observed that the modified trinkle reduction drive device would not turn when attached to the small battery drive device. There were no delays to the surgical procedure as an identical spare device was available for use to complete the surgery. There was 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 | 8030965-2017-13925 |
| MDR Report Key | 6749771 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-28 |
| Date of Report | 2017-07-06 |
| Date of Event | 2017-07-06 |
| Date Mfgr Received | 2017-08-01 |
| Device Manufacturer Date | 2011-02-15 |
| Date Added to Maude | 2017-07-28 |
| 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 | MODIFIED TRINKLE REDUCTION DRIVE UNIT |
| Generic Name | DRIVER, SURGICAL, PIN |
| Product Code | GFC |
| Date Received | 2017-07-28 |
| Returned To Mfg | 2017-07-25 |
| Catalog Number | 532.020 |
| Lot Number | MA1044 |
| 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 POWER TOOLS |
| Manufacturer Address | HAUPTSTRASSE 24 WALDENBURG CH4437 SZ CH4437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-28 |