FDA Adverse Event
Malfunction
Summary report: N
KATOR SUTURE ANCHOR 5MM X 25MM, #2 SUTURE, ARTHROSCOPIC
MDR report key: 6311835
·
Received February 8, 2017
Report
- Report Number
- 3012103994-2017-00001
- Event Type
- Malfunction
- Date Received
- February 8, 2017
- Date of Event
- January 10, 2017
- Report Date
- January 10, 2017
- Manufacturer
- KATOR LLC
- Product Code
- MBI
- UDI-DI
- B18610305920
- PMA / PMN Number
- K162386
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
DURING ARTHROSCOPIC ROTATOR-CUFF-REPAIR SURGERY, THE BREAKAWAY HEAD ON THE SUTURE ANCHOR BROKE PREMATURELY AND PRIOR TO SUTURE LOCK OUT. THE ANCHOR AND LOCKING PIN WERE REMOVED AND THE SUTURES WERE UNTHREADED FROM THE ANCHOR. A SECOND ANCHOR WAS PLACED AND PERFORMED AS INTENDED. THE FINAL SURGICAL RESULT WAS AS DESIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93540 | KATOR SUTURE ANCHOR 5MM X 25MM, #2 SUTURE, ARTHROSCOPIC | SUTURE ANCHOR | MBI | KATOR LLC | 103-0592 | 0096 | B18610305920 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |