FDA Adverse Event
Malfunction
Summary report: N
TWINFIX FT TI RC 4.5
MDR report key: 2020393
·
Received March 16, 2011
Report
- Report Number
- 1219602-2011-00042
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- January 25, 2011
- Report Date
- February 8, 2011
- Manufacturer
- SMITH & NEPHEW ENDOSCOPY
- Product Code
- MBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING EVALUATION THE TIP IS BROKEN OFF THE DEVICE. CONCLUSION COULD NOT BE MADE FOR THE REPORTED DEVICE FAILURE.(B)(6)
Description of Event or Problem · 1
WHEN THE DR. STARTED TO TURN ANCHOR INSIDE BONE THE ANCHOR TIP SNAPPED. SECOND ANCHOR TIP BENT WHEN DR TAPPED INSERTER WITH HAMMER. PER MALFUNCTION REPORT, THE TIP OF THE ANCHOR REMAINS IN THE PATIENT. AXIAL ALIGNMENT WAS MAINTAINED. AND THE AO 2 FINGER TECHNIQUE WAS USED. SECOND ANCHOR TIP BENT WHEN DR. TAPPED INSERTER WITH HAMMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TWINFIX FT TI RC 4.5 | TWINFIX ULTRA 5.5MM W/3 UB | MBI | SMITH & NEPHEW ENDOSCOPY | 72202897 | 50337542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |