FDA Adverse Event
Malfunction
Summary report: N
BIOSTEON WEDGE INTERFERENCE SCREW
MDR report key: 2881235
·
Received November 12, 2012
Report
- Report Number
- 9617083-2012-00030
- Event Type
- Malfunction
- Date Received
- November 12, 2012
- Date of Event
- October 5, 2012
- Manufacturer
- BIOCOMPOSITES LTD.
- Product Code
- HWC
- PMA / PMN Number
- K0003641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE LIMITED INFO REC'D, SUSPECTED ROOT CAUSES ARE: USE OF DAMAGED OR 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 THE INSERTION OF THE SCREW IN THE BONE, THE SCREW AND THE SCREWDRIVER BROKE OFF. THE SURGEON REMOVED THE BROKEN PRODUCT FROM THE PT AND COMPLETED SUCCESSFULLY THE PROCEDURE USING ANOTHER ITEM AVAILABLE IN THE THEATRE. NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSTEON WEDGE INTERFERENCE SCREW | BONE SCREW | HWC | BIOCOMPOSITES LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |