FDA Adverse Event
Malfunction
Summary report: N
TWIST DRILL D3.2, L 195, COIL 50, QUICK COUPLI
MDR report key: 3905742
·
Received May 28, 2014
Report
- Report Number
- 8043862-2014-00003
- Event Type
- Malfunction
- Date Received
- May 28, 2014
- Date of Event
- April 30, 2014
- Report Date
- May 27, 2014
- Manufacturer
- AAP IMPLANTATE AG
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DRILL HAS BEEN RETURNED BENT AND THE TOP HAS BEEN BROKEN OFF. USUALLY A BENDING OF HARDENED MATERIAL IS NOT POSSIBLE WHEN DRILLING INTO BONE. IT SEEMS THAT THE DRILL TOUCHES EITHER ANOTHER INSTRUMENT OR AN IMPLANT HAD THE TOP BROKE OF AFTER BENDING.
Description of Event or Problem · 1
DRILL BIT WAS BENT DURING AND THEN BROKE. IT IS NOT KNOWN IF THE TOP OF THE DRILL WHICH BROKE OFF REMAINS IN THE BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 315079 | TWIST DRILL D3.2, L 195, COIL 50, QUICK COUPLI | DRILL BIT | HTW | AAP IMPLANTATE AG | IU 7432-00 | I032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |