MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-26 for SYNTHES MALLET 399.43 manufactured by Synthes.
[55921402]
During hip case wooden handle on mallet began to break apart along the metal rivets during the case. All broken pieces retrieved. No pieces fell into patient/sterile field and no injuries to any employees.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065067 |
| MDR Report Key | 5983008 |
| Date Received | 2016-09-26 |
| Date of Report | 2016-09-14 |
| Date of Event | 2016-09-07 |
| Date Added to Maude | 2016-09-28 |
| 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 | SYNTHES MALLET |
| Generic Name | MALLET |
| Product Code | HXL |
| Date Received | 2016-09-26 |
| Catalog Number | 399.43 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-26 |