FDA Adverse Event
Malfunction
Summary report: N
ULTRA FAST-FIX ASSEMBLY - CURVED, EI
MDR report key: 6700441
·
Received July 11, 2017
Report
- Report Number
- 1219602-2017-00746
- Event Type
- Malfunction
- Date Received
- July 11, 2017
- Date of Event
- June 14, 2017
- Report Date
- July 21, 2017
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- GAT
- PMA / PMN Number
- K121861
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6).
Additional Manufacturer Narrative · 1
A VISUAL ASSESSMENT OF THE DEVICE CONFIRMED THE REPORTED COMPLAINT. APPROXIMATELY 12 INCHES OF SUTURE WAS RETURNED FOR EXAMINATION, WHICH SHOWED THE BLUE POLYPROPYLENE MONOFILAMENT HAS BEEN BROKEN/TORN FROM THE SUTURE. THE RETURNED PHOTOGRAPH SHOWS THE MONO BREAKING WHEN SNUGGING DOWN THE KNOT AIDED BY A PROBE; AS A RESULT A SMALL PIECE OF THE MONO BECAME FREE FLOATING WITHIN THE JOINT SPACE. IT APPEARS THE PROBE LIKELY STRETCHED THE MONO TO ITS BREAKING POINT CAUSING THE LOOSE BODY. PER THE DEVICE IFU ¿TO FURTHER SNUG DOWN THE SUTURE CONSTRUCT, THREAD THE FREE END OF THE SUTURE THROUGH THE KNOT PUSHER/SUTURE CUTTER¿. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THE BLUE SUTURE DISSOLVED (BROKE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 484955 | ULTRA FAST-FIX ASSEMBLY - CURVED, EI | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | GAT | SMITH & NEPHEW, INC. | 50622626 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |