FDA Adverse Event
Malfunction
Summary report: N
OSTEO-MED
MDR report key: 599268
·
Received April 28, 2005
Report
- Report Number
- MW1035332
- Event Type
- Malfunction
- Date Received
- April 28, 2005
- Date of Event
- April 18, 2005
- Report Date
- April 28, 2005
- Manufacturer
- OSTEOMED, LP
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING A LEFT BUNIONECTOMY, TWO OSTEO-MED DRILL BITS 01.3 #3200016 AND #3200010 BROKE OFF IN THE PT'S METATARSAL BOTH APPEARING TO BE IN THE INTRA-MEDULLARY CANAL. THE SURGEON PROCEEDED TO IMPLANT INTERNAL FIXATION WITH OSTEO-MED MINI LAG SCREW #30602418, 2.4 MM X 18 MM IN THE SAME AREA. THE SURGEON LEFT THE BROKEN DRILL BITS IN THE BONE BECAUSE HE FELT THAT REMOVING THEM WOULD "CAUSE MORE DAMAGE" TO THE INTEGRITY OF THE BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSTEO-MED | DRILL BITS - FROM M-3X SYSTEM | HTW | OSTEOMED, LP | NA | NA | |
| 2 | OSTEO-MED | DRILL BITS FROM M-3X SYSTEM | HTW | OSTEOMED, LP | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |