FDA Adverse Event
Injury
Summary report: N
DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/100MM-STERILE
MDR report key: 1199316
·
Received October 15, 2008
Report
- Report Number
- 3003506883-2008-00026
- Event Type
- Injury
- Date Received
- October 15, 2008
- Date of Event
- September 19, 2008
- Report Date
- September 22, 2008
- Manufacturer
- SYNTHES (USA)
- Product Code
- HWC
- PMA / PMN Number
- K964259
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION DRAWN, AS NO DEVICE WAS RETURNED. A DEVICE HISTORY RECORD WAS PERFORMED WITH NO PERTINENT NONCONFORMANCE'S NOTED. THE LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURER AND RELEASE.
Description of Event or Problem · 1
WHEN ATTEMPTING TO PLACE A DHS PLATE, THE SURGEON NOTED THAT THE PLATE COULD NOT SLIDE DOWN THE LAG SCREW BARREL. SURGEON IMPACTED THE PLATE. THE LAG SCREW PERFORATED THE FEMORAL HEAD. HARDWARE WAS REMOVED AND PATIENT WAS REVISED TO HEMIARTHROPLASTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/100MM-STERILE | DHS/DCS LAG SCREWS | HWC | SYNTHES (USA) | NA | 5744032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | DHS PLATE |