FDA Adverse Event
Malfunction
Summary report: N
FAST-FIX ULTRA CURVED NEEDLE DELIVERY SYS
MDR report key: 1112736
·
Received August 11, 2008
Report
- Report Number
- 1219602-2008-00199
- Event Type
- Malfunction
- Date Received
- August 11, 2008
- Date of Event
- June 26, 2008
- Report Date
- June 26, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- GAS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT BEING RETURNED FOR EVALUATION. THIS INCIDENT INITIALLY HAD THE DECISION TREE ASSESSMENT CHECKED OFF AS "NO" FOR REPORTABILITY DUE TO A SOFTWARE GLITCH IN THE DATABASE AND THEREFORE, WAS OVERLOOKED FOR INITIAL ASSESSMENT.
Description of Event or Problem · 1
DURING MENISCAL REPAIR, A PIECE OF THE DEVICE BROKE OFF AND WAS UNABLE TO BE FOUND IN THE JOINT. THE SURGEON PLACED BOTH TS WITHOUT ISSUE AND AS HE WAS CHECKING THE REPAIR, HE NOTICED THAT T1 WAS FREE FLOATING IN THE JOINT AND COULD NOT BE RETRIEVED. T2 AND THE SUTURE WERE REMOVED, AND AN ADD'L DEVICE WAS USED TO COMPLETE THE REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FAST-FIX ULTRA CURVED NEEDLE DELIVERY SYS | FAST-FIX | GAS | SMITH & NEPHEW INC., ENDOSCOPY DIV. | 72201491 | 50253218 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |