FDA Adverse Event
Malfunction
Summary report: N
TWINFIX FT HA RC 4.5
MDR report key: 2173559
·
Received July 23, 2011
Report
- Report Number
- 1219602-2011-00120
- Event Type
- Malfunction
- Date Received
- July 23, 2011
- Report Date
- June 23, 2011
- Manufacturer
- SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
- Product Code
- MAI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TWO DEVICES WERE RETURNED FOR EVALUATION. SAMPLE ONE THE DISTAL TIP OF THE ANCHOR AND SUTURE WERE NOT RETURNED. THE ANCHOR IS BROKEN AT THE SUTURE EYELET. THE TWO INSERTER ANCHOR TINES ARE BENT. SAMPLE TWO THE ANCHOR IS FRACTURED AT THE SUTURE EYELET. REMOVAL OF THE ANCHOR SHOWS ONE INSERTER TINE IS BENT OVER AND ONE HAS BROKEN OFF IN THE ANCHOR. WITHOUT KNOWING THE TECHNIQUE UTILIZED WHEN INSERTING THE ANCHORS A ROOT CAUSE CANNOT BE DETERMINED. (B)(4).
Description of Event or Problem · 1
THE IMPLANT BROKE DURING THE SURGERY. IMPOSSIBLE TO GET ANY FURTHER INFORMATION FROM THE USER. MANLFUNCTION REPORT STATES BROKEN PIECE WAS REMOVED MANUALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TWINFIX FT HA RC 4.5 | TWINFIX ULTRA HA 4.5 W/2 UB (WH & BLUE | MAI | SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE | 72202597 | 50359998 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |