FDA Adverse Event
Malfunction
Summary report: N
ACCU-PASS
MDR report key: 2872317
·
Received December 13, 2012
Report
- Report Number
- 1219602-2012-00340
- Event Type
- Malfunction
- Date Received
- December 13, 2012
- Date of Event
- November 1, 2012
- Report Date
- November 16, 2012
- Manufacturer
- SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
- Product Code
- HWQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT BEING RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION THE METAL TIP OF THE SUTURE, SHUTTLE BROKE OFF IN PATIENTS SHOULDER. IT IS UNKNOWN AT THIS TIME IF AND HOW THE METAL PIECE WAS REMOVED. ESTIMATED TIME OF DELAY TO THE CASE IS UNKNOWN. NO PATIENT INJURY REPORTED. A BACK UP DEVICE WAS ON HAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-PASS | ACCU-PASS STR SHUTTLE 45 | HWQ | SMITH & NEPHEW MANSFIELD MANUFACTURING SITE | 7210423 | 50415307 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |