FDA Adverse Event
Injury
Summary report: N
CORTICAL BONE SCR 50MM
MDR report key: 1040138
·
Received May 7, 2008
Report
- Report Number
- 1818910-2008-01338
- Event Type
- Injury
- Date Received
- May 7, 2008
- Date of Event
- March 27, 2008
- Report Date
- April 7, 2008
- Manufacturer
- DEPUY ACE S.A. 'R.L.
- Product Code
- HSB
- PMA / PMN Number
- K871539
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
IN 2008, INITIAL SURGERY WAS DONE WITH VERSANAIL TEN FOR FRACTURE OF SHAFT OF FEMUR. AFTER THE SURGERY, IT WAS FOUND THAT THE SCREW USED FOR THE PROXIMAL PART OF THE NAIL WAS BROKEN. THE CAUSE OF THE BREAKAGE WAS UNKNOWN. TWENTY-THREE DAYS LATER, ANOTHER SURGERY WAS DONE TO REMOVE THE BROKEN SCREW OUT OF THE PATIENT'S BODY AND 5.5MM CORTICAL SCREW WAS USED INSTEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORTICAL BONE SCR 50MM | 87HSB | HSB | DEPUY ACE S.A. 'R.L. | NA | DFLBCF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention |