FDA Adverse Event
Malfunction
Summary report: N
SCREWDRIVER BIT AXSOS T20, AO FITTING 5.0MM LOCKI
MDR report key: 2191432
·
Received July 28, 2011
Report
- Report Number
- 8031020-2011-00168
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- July 5, 2011
- Report Date
- July 5, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. SAME PT EVENT AS MDR 8031020-2011-00167.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE POWER BIT WAS TWISTED AND COULD NOT FUNCTION. THE SCREWDRIVER TIP WAS SHEARED OFF."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREWDRIVER BIT AXSOS T20, AO FITTING 5.0MM LOCKI | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | 00140U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |