JACOBS CHUCK WITH KEY
Report
- Report Number
- 8030965-2013-11102
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Date of Event
- June 6, 2012
- Report Date
- June 12, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. PART RECEIVED ON UNKNOWN DATE. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT ONE OF THE CLAMPING JAWS IS BROKEN AND SEPARATED FROM THE CHUCK. THE RELEVANT DIMENSIONS CAN NOT BE VERIFIED ANYMORE BECAUSE OF THE DAMAGE. ALSO IT CAN NOT BE DEFINED ANYMORE IF THE ASSEMBLING WAS CARRIED OUT PROPERLY BECAUSE THE JAW IS SEPARATED. THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. WE CAN ONLY ASSUME THAT HIGH VIBRATIONS IN COMBINATION WITH HIGH LOADS COULD HAVE CAUSED THIS OCCURRENCE.
DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE USED FOR A VETERINARY PROCEDURE.
IT WAS REPORTED THAT ONE OF THE CLAMPING JAWS FELL OUT OF THE CHUCK UNIT. NO INJURY TO ANIMAL PATIENT WAS REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184995 | JACOBS CHUCK WITH KEY | HWE | SYNTHES GMBH | 7665123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |