FDA Adverse Event
Malfunction
Summary report: N
ULTRA FAST-FIX ASSEMBLY - CURVED
MDR report key: 7612158
·
Received June 18, 2018
Report
- Report Number
- 1219602-2018-00763
- Event Type
- Malfunction
- Date Received
- June 18, 2018
- Date of Event
- May 2, 2018
- Report Date
- June 18, 2018
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- GAT
- UDI-DI
- 03596010597205
- PMA / PMN Number
- K072322
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ONE CURVED ULTRA FAST-FIX ASSEMBLY WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT SHOWED THE TRIGGER HAS BEEN FULLY ADVANCED AND LOCKED WITHIN THE HANDLE INDICATING A COMPLETE DEPLOYMENT. TS AND SUTURE WERE NOT RETURNED. DEPTH LIMITER HAS BEEN TRIMMED TO THE SURGEONS DESIRED LENGTH. DEVICE WAS NOT RETURNED IN THE CONDITION OF THE REPORTED COMPLAINT OF T1 PRE-DEPLOYMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT SOMETHING OF THE DEVICE WAS FELL OFF BEFORE THE SURGERY, SURGEON TRIED TO FIX IT, BUT WHEN USED, IT STILL FELL OFF. THERE WAS NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451559 | ULTRA FAST-FIX ASSEMBLY - CURVED | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | GAT | SMITH & NEPHEW, INC. | 72201491 | 50674116 | 03596010597205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |