FDA Adverse Event
Malfunction
Summary report: N
TWIST DRILL D2.7, L 150, COIL 50, QUICK COUPLI
MDR report key: 3905786
·
Received May 28, 2014
Report
- Report Number
- 8043862-2014-00005
- 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 AND THE TOP HAS BEEN BROKEN OFF. ALL PIECES HAVE BEEN RETURNED. THE CONTROL OF THE DEVICE HISTORY FILE AND THE QUALITY CONTROL DOCUMENTATION SHOWED NO DEVIATION FROM THE SPECIFICATION. THEREFORE THE BREAKAGE OCCURRED BY ACCIDENT AS A STATISTIC FAILURE.
Description of Event or Problem · 1
DRILL BIT BROKE OFF DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314857 | TWIST DRILL D2.7, L 150, COIL 50, QUICK COUPLI | DRILL BIT | HTW | AAP IMPLANTATE AG | IU 7427-15 | K003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |