FDA Adverse Event
Malfunction
Summary report: N
2520274-2014-01050
MDR report key: 4133777
·
Received October 1, 2014
Report
- Report Number
- 2520274-2014-01050
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Report Date
- April 11, 2013
- Manufacturer
- SYNTHES (USA)
- Product Code
- HWE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.
Description of Event or Problem · 1
CUSTOMER REPORTED THE MOTOR HEATS UP. THIS IS REPORT 2 OF 2 FOR UNKNOWN POWER TOOL FOR #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611729 | HWE | SYNTHES (USA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |