FDA Adverse Event
Malfunction
Summary report: N
COLIBRI
MDR report key: 4153372
·
Received October 8, 2014
Report
- Report Number
- 8030965-2014-00518
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Report Date
- May 6, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- MOQ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- 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. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, INVESTIGATION REVEALED THE MOTOR WAS BLOCKED, ROUGH RUNNING AND SEIZED. THE DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER ON (B)(4) 2013. (B)(6). PLACEHOLDER.
Description of Event or Problem · 1
CUSTOMER REPORTED THE MOTOR MAKES LOUD NOISE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 630549 | COLIBRI | MOQ | SYNTHES GMBH | 9408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |