MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for DRILL BIT 323.062 323062 manufactured by Synthes (u.s.a.) Lp.
[185700016]
Patient sustained a gunshot wound to his left hand resulting in a comminuted, displaced and angulated fracture of his second metacarpal. Surgical intervention was recommended. During the procedure, a small distal portion of the drill bit broke off in the drilled screw hole in the bone. Per surgeon's notes: a piece of the drill bit broke off while placing a screw in the base of his second metacarpal during surgery. This piece of drill bit was retained within the bone and was not removed as it was felt to cause more harm in an effort to remove it rather than to leave it retained. It was approximately 1 cm piece of a 2mm drill bit that was retained in an intraosseous fashion. Patient was informed of this retained drill bit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902790 |
| MDR Report Key | 9902790 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-14 |
| Report Date | 2020-02-26 |
| Date Reported to FDA | 2020-02-26 |
| Date Reported to Mfgr | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | DRILL BIT |
| Generic Name | BIT, DRILL |
| Product Code | HTW |
| Date Received | 2020-03-31 |
| Model Number | 323.062 |
| Catalog Number | 323062 |
| Lot Number | L841878 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (U.S.A.) LP |
| Manufacturer Address | 1210 WARD AVE WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |