FDA Adverse Event
Malfunction
Summary report: N
SPEEDLOCK PLUS PROCEDURE SET (W/BLUE COBRAID
MDR report key: 3050389
·
Received April 8, 2013
Report
- Report Number
- 3006524618-2013-00139
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 8, 2013
- Report Date
- March 8, 2013
- Manufacturer
- ARTHROCARE CORPORATION
- Product Code
- MBI
- PMA / PMN Number
- K090615
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE USING THE SPEEDLOCK PLUS PROCEDURE SET, THE PEEK ANCHOR BROKE OFF WHILE INSIDE THE JOINT. THE ANCHOR WAS ABANDONED INSIDE THE BONE AND A NEW BONE HOLE WAS DRILLED, TO COMPLETE THE PROCEDURE USING A BACKUP ANCHOR. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142467 | SPEEDLOCK PLUS PROCEDURE SET (W/BLUE COBRAID | FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD | MBI | ARTHROCARE CORPORATION | 1019709 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other |