MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-04 for DEPUY IMPACT CHISEL 24210010000 manufactured by Depuy Synthes, Inc..
[132517874]
Surgeon performing total knee revision and during the surgery the impactor chisel from depuy broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082873 |
| MDR Report Key | 8222263 |
| Date Received | 2019-01-04 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-12-10 |
| Date Added to Maude | 2019-01-07 |
| 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 | UNKNOWN |
| 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 | DEPUY IMPACT CHISEL |
| Generic Name | CHISEL, SURGICAL, MANUAL |
| Product Code | FZO |
| Date Received | 2019-01-04 |
| Returned To Mfg | 2018-12-10 |
| Model Number | 24210010000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-04 |