FDA Adverse Event
Malfunction
Summary report: N
HOOK, CROCHET
MDR report key: 1627365
·
Received March 5, 2010
Report
- Report Number
- 1219602-2010-00043
- Event Type
- Malfunction
- Date Received
- March 5, 2010
- Date of Event
- February 4, 2010
- Report Date
- February 4, 2010
- Manufacturer
- MANSFIELD MANUFACTURING SITE
- Product Code
- NBH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RECEIVED BY S&N FOR EVALUATION. (B) (4)
Description of Event or Problem · 1
TIP OF THE DEVICE BROKE OFF WHEN THE SURGEON TRIED TO PULL THE SUTURE FROM THE TIBIAL BONE TUNNEL TO THE ANTERIOR PORTAL. IT WAS NOT CONFIRMED IF THE BROKEN PIECE FELL OFF IN THE JOINT. THE PIECE IS SO SMALL, IT COULD NOT BE CONFORMED VIA X-RAY. EM (B) (6) 2010 TO SEE IF SITE WAS FLUSHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOOK, CROCHET | HOOK, CROCHET / NBH | NBH | MANSFIELD MANUFACTURING SITE | 7209145 | 50097664 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |