FDA Adverse Event
Injury
Summary report: N
BIPASS DISPOSABLE PUSHER SINGLE PACK
MDR report key: 2132765
·
Received June 17, 2011
Report
- Report Number
- 1825034-2011-00517
- Event Type
- Injury
- Date Received
- June 17, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 25, 2011
- Manufacturer
- BIOMET SPORTS MEDICINE
- Product Code
- HXO
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION OF THE RETURNED DEVICE FOUND THAT IT FUNCTIONED AS INTENDED.THIS REPORT FILED (B)(4), 2011.
Additional Manufacturer Narrative · 1
REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE UTILIZING A NITINOL WIRE PUSHER ON (B)(6) 2011. DURING THE PROCEDURE, THE NITINOL WIRE PUSHER WOULD NOT PASS THE SUTURE THROUGH THE PATIENT'S ROTATOR CUFF AND REPORTEDLY BENT. ANOTHER NITINOL WIRE PUSHER WAS ATTEMPTED WITH THE SAME RESULT. THIS CAUSED A DELAY OF GREATER THAN THIRTY MINUTES TO THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPASS DISPOSABLE PUSHER SINGLE PACK | PUSHER | HXO | BIOMET SPORTS MEDICINE | N/A | 343600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |