FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1971156
·
Received January 18, 2011
Report
- Report Number
- 1971156
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- January 3, 2011
- Report Date
- January 18, 2011
- Manufacturer
- THE ANSPACH EFFORT
- Product Code
- HBF
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
DR. PERFORMING CRANIAL FLAP WITH THE DRILL, IT WAS NOTED BY DR. THAT THE DISTAL END OF THE DRILL BIT WAS MISSING. DR. IMMEDIATELY SEARCHED THE WOUND AND LOCATED THE MISSING PIECE. THE 2 PIECES WERE SEQUESTERED FOR FOLLOW-UP AFTER THE CASE. THE MISSING PIECE MEASURED 5MM IN LENGTH. THE 2 PIECES WERE PLACED IN A BIOHAZARD BAG AND KEPT FOR FOLLOW UP WITH ANSPACH. THE ANSPACH REP WAS INFORMED OF THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) | HBF | THE ANSPACH EFFORT | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | NO OTHER THERAPIES |