FDA Adverse Event
Malfunction
Summary report: N
STEPDRILL FOR LAG SCREW
MDR report key: 1070431
·
Received June 30, 2008
Report
- Report Number
- 9610622-2008-00100
- Event Type
- Malfunction
- Date Received
- June 30, 2008
- Date of Event
- June 5, 2008
- Report Date
- June 6, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
DURING T2 RECON NAIL SURGERY, THE TIP OF STEP DRILL BROKE INSIDE THE FEMORAL BONE BECAUSE THE STEP DRILL WAS CONTACTING THE NAIL WHEN INSERTING THE STEP DRILL. THE SURGEON REMOVED THE TIP. THE SURGEON USED ANOTHER STEP DRILL, AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM. THE SURGEON CHECK THE TARGET DEVICE AND CONFIRMED THAT THE STEP DRILL COULD GO INTO THE LAG SCREW HOLE OF THE NAIL PRIOR TO USE FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEPDRILL FOR LAG SCREW | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |