FDA Adverse Event
Injury
Summary report: N
SYNTHES QUICK COUPLING DRILL BIT
MDR report key: 1520344
·
Received October 29, 2009
Report
- Report Number
- MW5013272
- Event Type
- Injury
- Date Received
- October 29, 2009
- Date of Event
- October 23, 2009
- Report Date
- October 29, 2009
- Manufacturer
- SYNTHES, INC
- Product Code
- HTW
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING SURGERY FOR HAMMER TOE AND BUNIONS, A 1.5 DRILL BIT BROKE OFF IN A PT'S RIGHT 2ND METATARSAL BONE. APPROXIMATELY .5 INCH OF THE DRILL WAS LEFT IN THE BONE. THE SURGEON DETERMINED THE DRILL BIT PIECE WAS UNRETRIEVABLE. NEW DRILL BIT. DIAGNOSIS: SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNTHES QUICK COUPLING DRILL BIT | DRILL BIT, 1.5MM | HTW | SYNTHES, INC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |