FDA Adverse Event
Malfunction
Summary report: N
BIPASS DISPOSABLE NITINOL
MDR report key: 1629070
·
Received March 11, 2010
Report
- Report Number
- 1825034-2010-00082
- Event Type
- Malfunction
- Date Received
- March 11, 2010
- Date of Event
- February 3, 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 SURGEON MADE UNSUCCESSFUL ATTEMPTS TO PASS THE SUTURE THROUGH THE ROTATOR CUFF. THE TIP OF THE NITINOL WIRE FRACTURED BUT COULD NOT BE LOCATED. SURGEON SEARCHED THE JOINT SPACE HOWEVER, NO RADIOGRAPHS WERE TAKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPASS DISPOSABLE NITINOL | PUSHER | HXO | BIOMET SPORTS MEDICINE | N/A | 592170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |