FDA Adverse Event
Malfunction
Summary report: N
SET SCREWDRIVER BIT 4X190 MM
MDR report key: 1078935
·
Received July 16, 2008
Report
- Report Number
- 9610622-2008-00120
- Event Type
- Malfunction
- Date Received
- July 16, 2008
- Date of Event
- June 20, 2008
- Report Date
- June 24, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HXX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. NO EVALUATION WILL BE SUBMITTED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE RISK MANAGER FROM THE HOSPITAL, REPORTED THE FOLLOWING EVENT: DURING SURGERY, THE SURGEON SCREWED THE SCREW REF. 12060822S LOT K694400 WITH THE SCREWDRIVER. THE SURGEON DIDN'T HEAR THE "CLICK" AS USUAL AND HAD DIFFICULTIES REMOVING THE SCREWDRIVER FROM THE SCREW HEAD. DURING THE CLEANING AND STERILIZATION, IT WAS NOTICED THAT THE TIP OF THE SCREWDRIVER WAS MISSING. THE SURGEON ASSUMED THAT THE TIP REMAINED IN THE SCREW HEAD WHICH WAS IMPLANTED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SET SCREWDRIVER BIT 4X190 MM | INSTRUMENT | HXX | STRYKER OSTEOSYNTHESIS KIEL | NA | K743842 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |