FDA Adverse Event
Malfunction
Summary report: N
OSCILL-SAW-ATTACHM F/532.001 532.010 532
MDR report key: 4102393
·
Received September 19, 2014
Report
- Report Number
- 8030965-2014-01277
- Event Type
- Malfunction
- Date Received
- September 19, 2014
- Report Date
- February 8, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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, IT WAS REVEALED THE COUPLING TOOL SIDE WAS WORN. THIS WAS ATTRIBUTED TO NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013. PLACEHOLDER.
Description of Event or Problem · 1
CUSTOMER REPORTED THE OPERATION IS POOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 582121 | OSCILL-SAW-ATTACHM F/532.001 532.010 532 | HWE | SYNTHES GMBH | 9307 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |