FDA Adverse Event
Malfunction
Summary report: N
BIOSTEON WEDGE INTERFERENCE SCREW
MDR report key: 2601119
·
Received May 24, 2012
Report
- Report Number
- 9617083-2012-00009
- Event Type
- Malfunction
- Date Received
- May 24, 2012
- Date of Event
- May 1, 2012
- Report Date
- May 23, 2012
- Manufacturer
- BIOCOMPOSITES LTD.
- Product Code
- HWC
- PMA / PMN Number
- K0003641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUSPECTED ROOT CAUSE: AS THE SURGEON DID NOT USE A DILATOR DURING THIS CASE, THIS MAY HAVE RESULTED IN EXCESSIVE TORQUE BEING APPLIED, WHICH RESULTED IN SCREW FAILURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FIXATING STG ACL RECONSTRUCTION FEMORAL TUNNEL WITH SCREW, AFTER TURNING THE SCREW HALFWAY IN, IT BROKE OFF. A GRASPER AND EASY OUT WAS USED TO REMOVE PIECES. ANOTHER SCREW OF SAME WAS USED TO SECURE STG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSTEON WEDGE INTERFERENCE SCREW | BONE SCREW | HWC | BIOCOMPOSITES LTD. | 1110PH911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention |