FDA Adverse Event
Malfunction
Summary report: N
TWINFIX ANCHOR
MDR report key: 1024270
·
Received March 27, 2008
Report
- Report Number
- 1219602-2008-00078
- Event Type
- Malfunction
- Date Received
- March 27, 2008
- Date of Event
- February 28, 2008
- Report Date
- February 29, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- MBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT IS BEING RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THE PATIENT HAD INITIAL SURGERY IN 2007, AND REVISION SURGERY IN 2008 TO REMOVE THE BROKEN ANCHOR THAT HAD PULLED OUT FROM THE CO-BRAID SUTURE EYELET AND WAS FLOATING AROUND IN THE SHOULDER. THE HEALING CUFF WAS FINE. THE SURGEON REVISED THE REPAIR WITH A TWO, SIDE TO SIDE SUTURE REPAIRS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TWINFIX ANCHOR | TWINFIX ANCHOR | MBI | SMITH & NEPHEW INC., ENDOSCOPY DIV. | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |