PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE
Received Jun 30, 2020
Report 2939274-2020-03038 · MDR key 10213528
Device
Generic name
Elevator
Manufacturer
Wrights Lane Synthes Usa Products LlcModel number
399.36Catalog number
399.36
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.
Description of Event or Problem
IT WAS REPORTED THAT DURING STERILIZATION OF THE DEVICE ON (B)(6) 2020, TWO (2) 6 MM CURVED BLADE PERIOSTEAL ELEVATOR WAS OBSERVED BROKEN. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) PERIOSTEAL ELEVATOR 6 MM CURVED BLADE-ROUND EDGE THIS IS REPORT 2 OF 2 FOR (B)(4).