ELECTRIC PEN DRIVE 90,000 RPM
Report
- Report Number
- 8030965-2013-10938
- Event Type
- Malfunction
- Date Received
- April 17, 2013
- Date of Event
- July 21, 2011
- Report Date
- July 21, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWE
- PMA / PMN Number
- K043310
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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. (B)(4). PLACEHOLDER.
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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(4).
SURGEON ORDERED TWO ELECTRIC PEN DRIVES. ONE OF THE PEN DRIVES DID NOT RUN AT ALL AND THE OTHER RAN SPORADICALLY. BOTH WERE BRAND NEW, OUT OF THE BOX. NEITHER OF THE TWO COULD BE USED IN SURGERY. THIS IS 2 OF 2 REPORTS FOR THIS EVENT, (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 164697 | ELECTRIC PEN DRIVE 90,000 RPM | HWE | SYNTHES GMBH | 1280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |