FDA Adverse Event
Malfunction
Summary report: N
TWINFIX TI 5.0 PROLOADED ANCHOR W/O NEEDLES
MDR report key: 576347
·
Received February 13, 2004
Report
- Report Number
- 1219602-2004-00019
- Event Type
- Malfunction
- Date Received
- February 13, 2004
- Date of Event
- January 22, 2004
- Report Date
- February 13, 2004
- Manufacturer
- SMITH & NEPHEW, INC. ENDOSCOPY DIVISION
- Product Code
- MBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SALES REPRESENTATIVE REPORTED THAT THIS ANCHOR BROKE DURING INSERTION. MALFUNCTION REPORT FORM CONFIRMED THAT THE BROKEN PIECES OF THIS ANCHOR WERE REMOVED FROM THE PATIENT AND A 20 MINUTE DELAY WAS EXPERIENCED. THE SURGEON DID HAVE A BACK-UP DEVICE AVAILABLE TO COMPLETE THE ROTATOR CUFF PROCEDURE WITH. SALES REP CONFIRMED THAT THE BONE WAS ABRADED AND THE SURGEON TAPPED THE BACK OF THE ANCHOR WITH A MALLET PRIOR TO INSERTION. NO PATIENT INJURY OR PROCEDURAL COMPLICATIONS RESULTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TWINFIX TI 5.0 PROLOADED ANCHOR W/O NEEDLES | TWINFIX TI 5.0 MM ANCHOR | MBI | SMITH & NEPHEW, INC. ENDOSCOPY DIVISION | 7210181 | 604529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |