FDA Adverse Event
Malfunction
Summary report: N
BIOSTEON WEDGE INTERFERENCE SCREW
MDR report key: 2980206
·
Received February 1, 2013
Report
- Report Number
- 9617083-2013-00003
- Event Type
- Malfunction
- Date Received
- February 1, 2013
- Date of Event
- December 24, 2012
- Report Date
- January 31, 2013
- Manufacturer
- BIOCOMPOSITES LTD.
- Product Code
- HWC
- PMA / PMN Number
- K0003641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE INFORMATION RECEIVED, POSSIBLE SUSPECTED ROOT CAUSES ARE: USE OF DAMAGED OR BENT DRIVER. FAILURE TO USE DILATOR FOR HSSTG GRAFT. GRAFT/SCREW/TUNNEL NOT APPROPRIATELY SIZED. INSERTION OVER BENT GUIDEWIRE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SCREW BROKE DURING ACL RECONSTRUCTION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45340 | BIOSTEON WEDGE INTERFERENCE SCREW | BONE SCREW | HWC | BIOCOMPOSITES LTD. | 0212PH311 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |