FDA Adverse Event
Malfunction
Summary report: N
CAD II
MDR report key: 4111273
·
Received September 23, 2014
Report
- Report Number
- 8030965-2014-01448
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Report Date
- December 11, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- 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. 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. (B)(6). DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE DEVICE WAS NOT FUNCTIONING PROPERLY. A REPLACEMENT DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT UPPER BUTTON STICKS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 590707 | CAD II | HWE | SYNTHES GMBH | 31956 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |