MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-07-11 for * 1181-100 manufactured by Zimmer Inc.
[21251437]
Pusher pin assembly broke during orif rt hip surgical procedure. The pin broke off in the pt's muscle and was retrieved in its entirely by the surgeon. A new zimmer set was opened and a new pin assembly was used without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 404533 |
| MDR Report Key | 404533 |
| Date Received | 2002-07-11 |
| Date of Report | 2002-07-08 |
| Date of Event | 2002-06-15 |
| Date Added to Maude | 2002-07-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | PUSHER FOR PIN ASSEMBLY |
| Product Code | GFC |
| Date Received | 2002-07-11 |
| Returned To Mfg | 2002-06-01 |
| Model Number | * |
| Catalog Number | 1181-100 |
| Lot Number | 70134300 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 393529 |
| Manufacturer | ZIMMER INC |
| Manufacturer Address | PO BOX 708 1800 WEST CENTER ST WARSAW IN 465800708 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-07-11 |