FDA Adverse Event
Malfunction
Summary report: N
5.0 ALLTHREAD TI3 3#2 MB
MDR report key: 2770748
·
Received October 3, 2012
Report
- Report Number
- 0001825034-2012-01797
- Event Type
- Malfunction
- Date Received
- October 3, 2012
- Date of Event
- September 3, 2012
- Report Date
- September 4, 2012
- Manufacturer
- BIOMET SPORTS MEDICINE
- Product Code
- MBI
- PMA / PMN Number
- PK110145
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. EVALUATION OF ANOTHER DEVICE FROM THE SAME LOT CONFIRMED REPORTED ISSUE.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A SUTURE ANCHOR ON (B)(6) 2012. DURING THE PROCEDURE, THE SURGEON OPENED A SUTURE ANCHOR, AND FOUND IT HAD TWO SUTURES INSTEAD OF THE EXPECTED THREE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE WITH NO REPORTED DELAY IN THE PROCEDURE OR PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.0 ALLTHREAD TI3 3#2 MB | FASTENER, FIXATION | MBI | BIOMET SPORTS MEDICINE | N/A | 035150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |