FDA Adverse Event
Malfunction
Summary report: N
ULTRA FAST-FIX ASSEMBLY - CURVED, EI
MDR report key: 7316912
·
Received March 6, 2018
Report
- Report Number
- 1219602-2018-00293
- Event Type
- Malfunction
- Date Received
- March 6, 2018
- Date of Event
- February 19, 2018
- Report Date
- April 10, 2018
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- GAT
- UDI-DI
- 00885554028591
- PMA / PMN Number
- K121861
- 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 HAS NOT BEEN RETURNED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE RETURN OF THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ULTRA FAST FIX T2 DID NOT TRIGGERED. ALL T'S WERE REMOVED. THERE WAS NO DELAY OR PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 161686 | ULTRA FAST-FIX ASSEMBLY - CURVED, EI | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | GAT | SMITH & NEPHEW, INC. | 50690104 | 00885554028591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |