FDA Adverse Event
Malfunction
Summary report: N
BIPASS DISPOSABLE NITINOL
MDR report key: 1629064
·
Received March 11, 2010
Report
- Report Number
- 1825034-2010-00081
- Event Type
- Malfunction
- Date Received
- March 11, 2010
- Date of Event
- February 12, 2010
- Report Date
- February 17, 2010
- Manufacturer
- BIOMET SPORTS MEDICINE
- Product Code
- HXO
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT FILED (B)(6) 2010.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE UTILIZING A SUTURE PASSER ON (B)(6) 2010. DURING THE PROCEDURE, THE NITINOL WIRE FRACTURED INSIDE THE PASSER AND WOULD NOT PUSH THE SUTURE. THERE WAS NO DELAY TO THE PROCEDURE OR INJURY TO THE PATIENT AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPASS DISPOSABLE NITINOL | PUSHER | HXO | BIOMET SPORTS MEDICINE | N/A | 875450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |