FDA Adverse Event
Malfunction
Summary report: N
SCREWDRIVER, SELF-HOLDING, EXTRA SHORT 3.5 MM
MDR report key: 1190563
·
Received October 2, 2008
Report
- Report Number
- 9610622-2008-00183
- Event Type
- Malfunction
- Date Received
- October 2, 2008
- Date of Event
- September 2, 2008
- Report Date
- September 8, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HXX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, THE SURGEON TRIED TO INSERT THE SCREW USING THE SELF HOLDING SCREW DRIVER. HOWEVER, THE SURGEON FOUND A CRACK ON THE TIP OF THE SLEEVE. THUS, THE SURGEON USED ANOTHER SCREW DRIVER INSTEAD AND THE PROCEDURE WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREWDRIVER, SELF-HOLDING, EXTRA SHORT 3.5 MM | INSTRUMENT | HXX | STRYKER OSTEOSYNTHESIS KIEL | NA | KMW350705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |