MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for JOINT RECON AWL INSTRUMENTS manufactured by Depuy Orthopedics Inc.
[131211103]
On (b)(6) 2018, patient underwent closed displaced oblique fracture of shaft of left ulna. Awl instrumentation tip broken off during use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082249 |
| MDR Report Key | 8176162 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-12-04 |
| Date Added to Maude | 2018-12-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JOINT RECON AWL INSTRUMENTS |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2018-12-17 |
| Lot Number | 1534801-C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPEDICS INC |
| Manufacturer Address | WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-17 |