FDA Adverse Event
Malfunction
Summary report: N
SPEEDSCREW KNOTLESS IMPLANT W/INSERTER HANDLE
MDR report key: 2852944
·
Received November 27, 2012
Report
- Report Number
- 3006524618-2012-00927
- Event Type
- Malfunction
- Date Received
- November 27, 2012
- Date of Event
- October 31, 2012
- Report Date
- October 31, 2012
- Manufacturer
- ARTHROCARE CORPORATION
- Product Code
- GEI
- PMA / PMN Number
- K081893
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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 KNOTLESS IMPLANT AND THE PERFECTPASSER MAGNUMWIRE SUTURE CARTRIDGE, AFTER WINDING ONE SIDE OF THE TIGHTENING MECHANISM IT BEGAN TO SPIN FREELY AS IF IT HAD ALREADY DEPLOYED. THE ANCHOR AS ULTIMATELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING AN ARTHREX 6.5 IMPLANT. THERE WAS NO SIGNIFICANT DELAY OR FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPEEDSCREW KNOTLESS IMPLANT W/INSERTER HANDLE | ELECTROSURGICAL CUTTER & COAGULATION DE | GEI | ARTHROCARE CORPORATION | 1025235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | OM-8175EA LOT # 1025491| PERFECTPASSER MAGNUMWIRE SUTURE CARTRIDGE |