FDA Adverse Event
Malfunction
Summary report: N
ULTRA FAST-FIX ASSEMBLY - CURVED, EI
MDR report key: 2954280
·
Received February 11, 2013
Report
- Report Number
- 1219602-2013-00033
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- January 16, 2013
- Report Date
- January 17, 2013
- Manufacturer
- SMITH & NEPHEW INC. MANSFIELD MANUFACTURING SITE
- Product Code
- GAT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DURING MENISCUS REPAIR PROCEDURE, WHEN PUSHED THROUGH MENISCUS AND FIRST T IMPLANT IN PLACE, THE SECOND T IMPLANT PUSHED FORWARD INTO READY POSITION, AS EXPECTED, HOWEVER, ON RETRACTION THROUGH SOFT TISSUE PRIOR TO SECOND T IMPLANT PLACEMENT THE SECOND IMPLANT FELL OFF AFTER CATCHING ON TISSUE. THIS OCCURRED ON 3 SEPARATE OCCASIONS DURING THE SAME CASE. THE T1 IMPLANT REMAINED INSIDE THE MENISCUS AND THE SURGEON WAS HAPPY TO LEAVE IT IN POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58750 | ULTRA FAST-FIX ASSEMBLY - CURVED, EI | ULTRA FAST-FIX ASSEMBLY | GAT | SMITH & NEPHEW INC. MANSFIELD MANUFACTURING SITE | 50425113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |