FDA Adverse Event
Malfunction
Summary report: N
FAST-FIX 360 CURVED NDL DELIVERY SYS
MDR report key: 6190345
·
Received December 20, 2016
Report
- Report Number
- 1219602-2016-01392
- Event Type
- Malfunction
- Date Received
- December 20, 2016
- Date of Event
- December 7, 2016
- Report Date
- January 19, 2017
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- GAT
- PMA / PMN Number
- K092508
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6)
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED AND NO RELEVANT CLINICAL INFORMATION WAS RECEIVED TO ASSIST IN THE EVALUATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE CLINICAL DETAILS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE T2 FAILED TO DEPLOY. BOTH THE T1 AND T2 ANCHORS WERE REMOVED FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 840552 | FAST-FIX 360 CURVED NDL DELIVERY SYS | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | GAT | SMITH & NEPHEW, INC. | 50612596 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |