FDA Adverse Event
Malfunction
Summary report: N
LAG SCREW STEP DRILL 10.5X495 MM
MDR report key: 1833549
·
Received September 8, 2010
Report
- Report Number
- 9610622-2010-00358
- Event Type
- Malfunction
- Date Received
- September 8, 2010
- Date of Event
- August 7, 2010
- Report Date
- August 13, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HWE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED DUE TO HOSPITAL POLICY. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, WENT TO REAM OVER THE K-WIRE AND INSERT THE LAG SCREW. THE LAG SCREW REAMER BENT AT THE BASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAG SCREW STEP DRILL 10.5X495 MM | INSTRUMENT | HWE | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 94 YR | Other |