FDA Adverse Event
Malfunction
Summary report: N
BIOSTEON WEDGE INTERFERENCE SCREW
MDR report key: 2489612
·
Received March 8, 2012
Report
- Report Number
- 9617083-2012-00003
- Event Type
- Malfunction
- Date Received
- March 8, 2012
- Date of Event
- January 6, 2012
- Report Date
- March 1, 2012
- Manufacturer
- BIOCOMPOSITES LTD.
- Product Code
- HWC
- PMA / PMN Number
- K0003641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUSPECTED ROOT CAUSE: ATTEMPTED INSERTION INTO A BONE TUNNEL THAT HAD NOT BEEN TAPPED, FOR A BPTB GRAFT, OR THE GRAFT/SCREW/TUNNEL WAS NOT APPROPRIATELY SIZED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY IMPLANTING THE DEVICE AND "DURING A KNEE SURGERY, WHILE TIGHTENING, THE SCREW FRACTURED". ADDITIONAL ANESTHESIA WAS REQUIRED FOR A TIME PERIOD GREATER THAN 30 MINUTES. THREE SCREWS WERE USED DURING THE PROCEDURE AND ALL BROKE-SEE REPORTS 9617083-2012-00004 AND 9617083-2012-00005.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSTEON WEDGE INTERFERENCE SCREW | BONE SCREW | HWC | BIOCOMPOSITES LTD. | 0711PH137 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |