FDA Adverse Event
Malfunction
Summary report: N
STANDARD DRILL BIT ANCHORAGE 2.0MM / L110MM, AO
MDR report key: 2945754
·
Received January 4, 2013
Report
- Report Number
- 8031020-2013-90002
- Event Type
- Malfunction
- Date Received
- January 4, 2013
- Date of Event
- December 12, 2012
- Report Date
- December 12, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HBE
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
SURGEON WAS DRILLING 3RD OR 4TH HOLE INTO METATARSAL PHALANGEAL REGION WHEN THE DRILL BIT BROKE OFF IN THE PATIENT'S BONE. X-RAY SHOWED IT WAS THERE AND ATTEMPTED TO GET IT OUT BUT WAS IMPOSSIBLE. SURGEON DECIDED TO LEAVE IT IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5048 | STANDARD DRILL BIT ANCHORAGE 2.0MM / L110MM, AO | INSTRUMENT | HBE | STRYKER OSTEOSYNTHESIS SELZACH | NA | C100266-10-00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other |