MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-19 for SHEPARDS HOOK RETRACTOR 00218110000 manufactured by Depuy.
[45880850]
Left total hip arthroplasty: physician placed a shepards hook retractor into left hip near the anterior portion of the acetabulum for soft tissue retraction. The distal small end of retractor that has a narrow tip had broken in place. The surgeon felt that by retrieving the broken metal tip, the pt would have tissue and bone trauma that could affect surgical outcomes. The surgeon made the decision to leave the small tip embedded in the pt as he believed that this did not pose any medical complication. There was no documented harm to the pt and the hospitalization course did not change because of the event. An op note was documented.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062443 |
| MDR Report Key | 5675329 |
| Date Received | 2016-05-19 |
| Date of Report | 2016-05-19 |
| Date of Event | 2016-05-13 |
| Date Added to Maude | 2016-05-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | SHEPARDS HOOK RETRACTOR |
| Generic Name | RETRACTO |
| Product Code | GZT |
| Date Received | 2016-05-19 |
| Model Number | 00218110000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY |
| Manufacturer Address | WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-19 |