FDA Adverse Event
Malfunction
Summary report: N
X-CHANGE ACET SCREWDRIVER
MDR report key: 1062283
·
Received June 17, 2008
Report
- Report Number
- 9610669-2008-00012
- Event Type
- Malfunction
- Date Received
- June 17, 2008
- Date of Event
- May 21, 2008
- Report Date
- May 22, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CAEN
- Product Code
- HXX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE SURGEON REPORTED THAT DURING A PROCEDURE THE SLEEVE HOLDING THE SCREW FELL INTO THE WOUND SEVERAL TIMES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X-CHANGE ACET SCREWDRIVER | INSTRUMENT | HXX | STRYKER ORTHOPAEDICS CAEN | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |