FDA Adverse Event
Malfunction
Summary report: N
BIOSTEON WEDGE INTERFERENCE SCREW
MDR report key: 2632641
·
Received June 22, 2012
Report
- Report Number
- 9617083-2012-00010
- Event Type
- Malfunction
- Date Received
- June 22, 2012
- Date of Event
- May 9, 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
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUSPECTED ROOT CAUSE: THE TUNNEL NOT BEING APPROPRIATELY SIZED AND ALSO, A DILATOR WAS NOT USED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING KNEE SURGERY ON (B)(6) 2012, WHEN INTRODUCING THE SCREW INTO THE TIBIAL TUNNEL, THE SCREW'S THREAD DAMAGED. THE CUSTOMER CLAIMED THAT ALL RULES WERE KEPT IN DETERMINING THE CORRECT INTRODUCING TUNNEL. 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 | 59 YR | Required Intervention |