AO/ASIF-QC F/532.001 532.010 532.101 532
Report
- Report Number
- 8030965-2013-00803
- Event Type
- Malfunction
- Date Received
- March 8, 2013
- Report Date
- February 11, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS USED IN A VETERINARY PROCEDURE. DEVICE WAS USED AS A VETERINARY PRODUCT. DEVICE IS MARKETED FOR HUMAN USE. HEALTH PROFESSIONAL IS VETERINARY PERSONNEL. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. WE FOUND THAT THE AO/ASIF QUICK COUPLING IS ROUGH-RUNNING, WHICH COULD LEAD TO A BLOCKAGE OF THE DEVICES DURING USE. THIS ISSUE WAS SOLVED AFTER A NORMAL SERVICE AT THESE DEVICES WAS PERFORMED. BASED ON THE RECEIVED INFORMATION WE ARE NOT ABLE TO DETERMINE THE OCCURRENCE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A VETERINARY SURGERY, IT WAS REPORTED THE DEVICE (SMALL BATTERY DRIVE 532.001) WAS BLOCKING SUDDENLY. REPORTEDLY THE BLOCKING HAPPENS WITH THE ATTACHMENT OF THE AO/ASIF QUICK COUPLING (05.001.250) AND ESPECIALLY WITH THE OSCILLATING SAW ATTACHMENT 532.021. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98954 | AO/ASIF-QC F/532.001 532.010 532.101 532 | HWE | SYNTHES GMBH | SER.-NR. 5098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |