FDA Adverse Event
Malfunction
Summary report: N
BIOSTEON WEDGE INTERFERENCE SCREW
MDR report key: 2632639
·
Received June 22, 2012
Report
- Report Number
- 9617083-2012-00012
- Event Type
- Malfunction
- Date Received
- June 22, 2012
- Date of Event
- May 21, 2012
- Report Date
- June 18, 2012
- Manufacturer
- BIOCOMPOSITES LTD.
- Product Code
- HWC
- PMA / PMN Number
- K0003641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUSPECTED ROOT CAUSE: BASED ON THE INFORMATION PROVIDED, IT IS DIFFICULT TO ASSIGN A ROOT CAUSE. POSSIBLE ROOT CAUSES ARE: USE OF DAMAGED/BENT DRIVER. FAILURE TO TAP IF BONE PATELLAR TENDON BONE GRAFT USED. GRAFT/SCREW/TUNNEL NOT APPROPRIATELY SIZED. INSERTION OVER A BENT GUIDEWIRE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A SURGERY (CRUCIATE LIGAMENTS), THE SCREW FRACTURED. THE SURGEON MANAGED TO EXTRACT THE SCREW AND PLACED ANOTHER SCREW OF THE SAME SIZE. THE SURGERY WAS SUCCESSFULLY COMPLETED AND NO ADVERSE CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSTEON WEDGE INTERFERENCE SCREW | BONE SCREW | HWC | BIOCOMPOSITES LTD. | 1111PH711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |