FDA Adverse Event
Malfunction
Summary report: N
SPEEDSCREW 5.5 IMPLANT PROCEDURE SET
MDR report key: 3050365
·
Received April 8, 2013
Report
- Report Number
- 3006524618-2013-00144
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 12, 2013
- Report Date
- March 12, 2013
- Manufacturer
- ARTHROCARE CORPORATION
- Product Code
- MBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE USING THE SPEEDSCREW 5.5 IMPLANT PROCEDURE SET, THE SURGEON ALLEGEDLY OVER TENSIONED THE DEVICE, CAUSING THE CROSS PIN TO BREAK. THE IMPLANT COULD NOT BE RETRIEVED FROM THE BONE, MAKING IT NECESSARY TO DRILL A NEW BONE HOLE. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACKUP IMPLANT. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142626 | SPEEDSCREW 5.5 IMPLANT PROCEDURE SET | FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD | MBI | ARTHROCARE CORPORATION | 1029370 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |