FDA Adverse Event
Malfunction
Summary report: N
SCREWDRIVER AXSOS T20 5.0MM LOCKING SET
MDR report key: 2020526
·
Received February 16, 2011
Report
- Report Number
- 8031020-2011-00041
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- January 31, 2011
- Report Date
- January 31, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, SURGEON DRILLED FOR A 5.0MM LOCKING SCREW (4.3MM DRILL). HE WAS IMPLANTING THE 5.0 LOCKING SCREW AND THE BLADE BROKE. HE WAS NOT USING POWER. IT WAS BY HAND. BROKE IN 2 PIECES. NOTHING WENT INTO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREWDRIVER AXSOS T20 5.0MM LOCKING SET | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |