FDA Adverse Event
Malfunction
Summary report: N
CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR
MDR report key: 4111384
·
Received September 23, 2014
Report
- Report Number
- 8030965-2014-01122
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Report Date
- March 12, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES 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. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE ADAPTOR HAS A BROKEN TOOTH. A REPLACEMENT WAS SENT TO THE CUSTOMER ON (B)(4) 2013. (B)(4). PLACEHOLDER.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE DEVICE DOES NOT FIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 589595 | CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR | HWE | SYNTHES GMBH | 30903 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |