FDA Adverse Event
Malfunction
Summary report: N
CURVTEK TSR SYSTEM
MDR report key: 235751
·
Received August 5, 1999
Report
- Report Number
- 2244702-1999-00001
- Event Type
- Malfunction
- Date Received
- August 5, 1999
- Date of Event
- June 7, 1999
- Report Date
- August 4, 1999
- Manufacturer
- BIOLECTRON, INC.
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DR. USING THE CURVTEK BONE DRILLING SYSTEM TO PERFORM A ROTATOR CUFF REPAIR EXPERIENCED THE FOLLOWING DEVICE FAILURE: DR. DRILLED ONE COMPLETE BONE TUNNEL WITHOUT DIFFICULTY. ON THE SECOND TUNNEL ONE OF THE DRILL BITS BROKE FREE FROM THE FLEXIBLE DRIVE SHAFT AND WAS EMBEDDED IN THE PATIENTS BONE. THE DRILL BIT WHICH WAS APPROX 1MM IN SIZE WAS NOT RECOVERED. THIS DRILL BIT IS FABRICATED OF MEDICAL GRADE STAINLESS STEEL AND WAS GAMMA STERILIZED PRIOR TO USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURVTEK TSR SYSTEM | PNEUMATIC DRILL SYSTEM | HTW | BIOLECTRON, INC. | 30-0202 | 911912 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |