FDA Adverse Event
Malfunction
Summary report: N
BIOSTEON WEDGE INTERFERENCE SCREW
MDR report key: 2632640
·
Received June 22, 2012
Report
- Report Number
- 9617083-2012-00011
- Event Type
- Malfunction
- Date Received
- June 22, 2012
- Date of Event
- May 29, 2012
- Report Date
- June 21, 2012
- Manufacturer
- BIOCOMPOSITES LTD.
- Product Code
- HWC
- PMA / PMN Number
- K0003641
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUSPECTED ROOT CAUSE: INSERTION OF THE SCREW INTO A BONE TUNNEL THAT IS TOO TIGHT FOR THE DIAMETER OF SCREW, SO THEREFORE, THE SCREW ROTATES, BUT DOES NOT ADVANCE INTO THE BONE TUNNEL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING SURGERY, WHEN INTRODUCING THE SCREW INTO THE ACL TUNNEL, THE SCREW'S THREAD DAMAGED AND THERE WAS NO POSSIBILITY TO INTRODUCE THE SCREW. NO ADVERSE CONSEQUENCES WERE REPORTED AS A REPLACEMENT SCREW OF THE SAME SIZE WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSTEON WEDGE INTERFERENCE SCREW | BONE SCREW | HWC | BIOCOMPOSITES LTD. | 0112PH31 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |