FDA Adverse Event
Malfunction
Summary report: N
SCREWDRIVER BIT AXSOS T20, AO FITTING 5.0MM LOCKI
MDR report key: 2191431
·
Received July 28, 2011
Report
- Report Number
- 8031020-2011-00166
- 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
- FR
- Reporter Occupation
- NURSE
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.
Description of Event or Problem · 1
THE NURSE REPORTED TO SALES REP THAT DURING SURGERY, THE SURGEON USED THE DEVICE ACCORDING TO THE OP TECHNIQUE. HE STARTED TO LOCK THE FIRST SCREW MANUALLY (WITHOUT THE USE OF A MOTOR). THE TIP OF THE BLADE FINALLY BROKE. AS THERE WAS ONLY ONE BLADE IN THE KIT, THE SURGEON COULD NOT USE LOCKING SCREWS AND USED SPS CORTICAL SCREWS TO FIX THE PLATE.
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 | 01261U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |