FDA Adverse Event
Malfunction
Summary report: N
2520274-2014-01016
MDR report key: 4124056
·
Received September 27, 2014
Report
- Report Number
- 2520274-2014-01016
- Event Type
- Malfunction
- Date Received
- September 27, 2014
- Report Date
- February 20, 2013
- Manufacturer
- SYNTHES (USA)
- Product Code
- HWE
- 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. 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 THAT THE COUPLING HANDPIECE OPERATED ON ITS OWN AND THEN THE COUPLING ATTACHMENT CAME APART. THIS IS REPORT 2 OF 2 FOR AN UNKNOWN POWER DEVICE FOR EVENT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 603362 | HWE | SYNTHES (USA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |