FDA Adverse Event
Malfunction
Summary report: N
ULTRA FAST-FIX ASSEMBLY - CURVED
MDR report key: 6105112
·
Received November 16, 2016
Report
- Report Number
- 1219602-2016-01253
- Event Type
- Malfunction
- Date Received
- November 16, 2016
- Date of Event
- October 26, 2015
- Report Date
- October 18, 2016
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- GAT
- PMA / PMN Number
- K072322
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. 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 DURING A MENISCUS REPAIR PROCEDURE T2 FELL OUT. T1 WAS REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 758303 | ULTRA FAST-FIX ASSEMBLY - CURVED | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | GAT | SMITH & NEPHEW, INC. | 50550782 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |