FDA Adverse Event
Malfunction
Summary report: N
PRESSFT
MDR report key: 3248833
·
Received July 24, 2013
Report
- Report Number
- 3248833
- Event Type
- Malfunction
- Date Received
- July 24, 2013
- Date of Event
- July 19, 2013
- Report Date
- July 24, 2013
- Manufacturer
- LINVATEC CORPORATION D/B/A CONMED LINVATEC
- Product Code
- MAI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MD, US
Narratives
Description of Event or Problem · 1
SURGEON ATTEMPTED IMPLANT OF SUTURE ANCHOR 2 TIMES. BOTH TIMES THE ANCHOR BROKE. ALL COMPONENTS WERE RETRIEVED. ANOTHER SUTURE ANCHOR WAS USED AND CASE COMPLETED. NO HARM TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ARTHROSCOPY- KNEE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346888 | PRESSFT | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE | MAI | LINVATEC CORPORATION D/B/A CONMED LINVATEC | * | 379258 | |
| 346889 | PRESSFT | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE | MAI | LINVATEC CORPORATION D/B/A CONMED LINVATEC | * | 379258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |