FDA Adverse Event
Malfunction
Summary report: N
TWINFIX ULTRA - PK
MDR report key: 3031504
·
Received April 2, 2013
Report
- Report Number
- 1219602-2013-00082
- Event Type
- Malfunction
- Date Received
- April 2, 2013
- Date of Event
- February 18, 2013
- Report Date
- March 5, 2013
- Manufacturer
- SMITH & NEPHEW INC MANSFIELD MANUFACTURING SITE
- Product Code
- MBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DURING ROTATOR CUFF REPAIR, SURGEON INSERTING ANCHOR USING STANDARD AWL TECHNIQUE, TIP OF IMPLANT BROKE OFF BEFORE ANCHOR WAS SEATED. THERE WERE THREE ANCHORS WITH THE SAME CAT NO AND LOT NUMBER THAT BROKE IN THIS CASE. BROKEN PIECED REMOVED BY PULLING OUT WITH SUTURE. E-MAIL CONFIRMED BACK UP ANCHOR WAS PUT IN A DIFFERENT HOLE, AND THE BONE OF PATIENT WAS VERY GOOD QUALITY, POSSIBLY ON THE HARD SIDE. DEVICE WILL NOT BEING RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134543 | TWINFIX ULTRA - PK | TWINFIX ULTRA PK 5.5MM W/2 UB-WHT & BL | MBI | SMITH & NEPHEW INC MANSFIELD MANUFACTURING SITE | 50426941 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |