INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE PICTURE REVIEW: IT IS NEITHER POSSIBLE TO VERIFY THE COMPLAINT CONDITION NOR DOES THE REVIEW ALLOW FOR ANY DETERMINATION OF THE ROOT CAUSE. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: PART # 338.26, SYNTHES LOT # FT00233, SUPPLIER LOT # FT00233, RELEASE TO WAREHOUSE DATE: 19 DEC 2016, SUPPLIER: FLEXTRONICS AMERICA LLC, NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
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Patient 1
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON FEBRUARY 26, 2020, THE DHS IMPACTOR WAS BROKEN DURING IMPACTION OF THE DHS PLATE. ANOTHER SET WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNK - PLATES: DHS/DCS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) TIP FOR DHS?/DCS? IMPACTOR (338.28). THIS IS REPORT 1 OF 1 FOR (B)(4).