FDA Adverse Event
Malfunction
Summary report: N
FASTFIX 360
MDR report key: 3191239
·
Received June 26, 2013
Report
- Report Number
- 1219602-2013-00144
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Date of Event
- April 8, 2013
- Report Date
- June 4, 2013
- Manufacturer
- MANSFIELD MANUFACTURING SITE
- Product Code
- GAT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DURING MENISCUS REPAIR IT WAS REPORTED THAT WHEN THE NEEDLE WAS PULLED OUT AFTER DEPLOYING T1, T2 IMPLANT FELL OFF FROM THE INSERTER NEEDLE WITHOUT PUSHING THE TRIGGER. ALTHOUGH T2 AND A PART OF THE SUTURE COULD BE REMOVED FROM THE PATIENT, T1 AND THE SUTURE TIE TO T1 REMAINS INSIDE THE BODY. SINCE THE DEVICE WAS DISPOSED AT THE FACILITY, IT WILL NOT BE RETURNED FOR EVALUATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291144 | FASTFIX 360 | FAST-FIX 360 REVERSED CURVE NDL DEL | GAT | MANSFIELD MANUFACTURING SITE | 72202469 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |