FDA Adverse Event
Malfunction
Summary report: N
CLOSED KNOT PUSHER
MDR report key: 1829334
·
Received September 9, 2010
Report
- Report Number
- 1825034-2010-00364
- Event Type
- Malfunction
- Date Received
- September 9, 2010
- Date of Event
- August 11, 2010
- Report Date
- August 13, 2010
- Manufacturer
- BIOMET SPORTS MEDICINE, INC.
- Product Code
- HXO
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- RES # 56589
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CLOSED KNOT PUSHER PART 902813 LOT 864100 SUBJECT OF RECALL.(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A CLOSED KNOT PUSHER ON (B)(6) 2010. DURING THE PROCEDURE, THE KNOT PUSHER CUT A SUTURE. AN ADDITIONAL SUTURE WAS IMPLANTED, BUT THE KNOT PUSHER CUT THAT ONE AS WELL. THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S KNOT PUSHER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLOSED KNOT PUSHER | PUSHER, SOCKET | HXO | BIOMET SPORTS MEDICINE, INC. | N/A | 864100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |