FDA Adverse Event
Malfunction
Summary report: N
QD11
MDR report key: 4182171
·
Received October 17, 2014
Report
- Report Number
- 1045834-2014-14259
- Event Type
- Malfunction
- Date Received
- October 17, 2014
- Report Date
- December 27, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- PK011444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES (B)(4) SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE CAME IN FOR SERVICE AND WAS REPAIRED BY THE TECHNICIAN. NO FURTHER INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BEARING WAS HOT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 661484 | QD11 | MOTOR, DRILL, ELECTRIC | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |