FDA Adverse Event
Malfunction
Summary report: N
SPEED SCREW 5.5 IMPLANT PROCEDURE SET
MDR report key: 3130178
·
Received May 22, 2013
Report
- Report Number
- 3006524618-2013-00204
- Event Type
- Malfunction
- Date Received
- May 22, 2013
- Date of Event
- April 29, 2013
- Report Date
- April 29, 2013
- Manufacturer
- ARTHROCARE CORPORATION
- Product Code
- MBI
- PMA / PMN Number
- K081893
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 SUTURES PULLED THROUGH THE CUFF UPON TIGHTENING THE SUTURE REELS. THE FACILITY OPTED TO COMPLETE THE PROCEDURE USING A COMPETITOR'S DEVICE. THERE WAS NO SIGNIFICANT DELAY OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227251 | SPEED SCREW 5.5 IMPLANT PROCEDURE SET | FIXATION ANCHOR, LIGAMENT, NON BIODEGRADABLE | MBI | ARTHROCARE CORPORATION | 1032428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other |