FDA Adverse Event
Malfunction
Summary report: N
5.0MM FLEXIBLE SHAFT
MDR report key: 3003687
·
Received February 28, 2013
Report
- Report Number
- 8030965-2013-10451
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- March 4, 2011
- Report Date
- March 14, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- HTO
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
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. THE SAMPLE WAS RECEIVED ALTHOUGH NO CONCLUSION COULD BE DRAWN BECAUSE PART IS STILL UNDER THE EVALUATION PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE REAMER HEAD AND FLEXIBLE SHAFT WERE BROKEN. THE REAM FLEXIBLE SHAFT TIP IS BROKEN OFF. ALL BROKEN PARTS ARE RESERVED. THIS COMPLAINT IS ON THE FLEXIBLE SHAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87008 | 5.0MM FLEXIBLE SHAFT | HTO | SYNTHES GMBH | 2317417 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |