MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-06 for SYNTHES MODULAR HAND SYSTEM manufactured by Synthes.
[49254334]
While using the synthes modular hand system for a metacarpal fracture, 2 screw heads fell off during the procedure. One from a 1. 5mm screw and one 1. 3mm screw. The 2 screw shafts remain as part of the implant in the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063312 |
| MDR Report Key | 5781742 |
| Date Received | 2016-07-06 |
| Date of Report | 2016-07-06 |
| Date of Event | 2016-06-21 |
| Date Added to Maude | 2016-07-11 |
| 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 MODULAR HAND SYSTEM |
| Generic Name | BONE FIXATION |
| Product Code | NDJ |
| Date Received | 2016-07-06 |
| 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 | 2016-07-06 |