MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-31 for BONE HOOK * UNKNOWN manufactured by Zimmer.
[16319457]
The stainless steel bone hook was being used to retract the bone when the tip broke off and stuck in the bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2412933 |
| MDR Report Key | 2412933 |
| Date Received | 2011-12-31 |
| Date of Report | 2011-12-31 |
| Date of Event | 2011-11-21 |
| Report Date | 2011-12-31 |
| Date Reported to FDA | 2011-12-31 |
| Date Added to Maude | 2012-01-12 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | BONE HOOK |
| Generic Name | BONE RETRACTOR |
| Product Code | HXO |
| Date Received | 2011-12-31 |
| Model Number | * |
| Catalog Number | UNKNOWN |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER |
| Manufacturer Address | 345 E. MAIN ST. WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-31 |