FDA Adverse Event
Other
Summary report: N
BOXED CHISEL
MDR report key: 4193963
·
Received October 15, 2014
Report
- Report Number
- 9613350-2014-03992
- Event Type
- Other
- Date Received
- October 15, 2014
- Date of Event
- September 17, 2014
- Report Date
- September 17, 2014
- Manufacturer
- ZIMMER GMBH
- Product Code
- KDG
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER DID NOT RECEIVE DEVICE AND PHOTOS FOR REVIEW. WHERE LOT NUMBER WAS RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A BOXED CHISEL INSTRUMENT WAS BROKEN DURING SURGERY ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655206 | BOXED CHISEL | BOXED CHISEL | KDG | ZIMMER GMBH | 14.969832 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |