BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE

    MDR report key: 5345076 · Received January 5, 2016

    Report

    Report Number
    3000270450-2016-10003
    Event Type
    Malfunction
    Date Received
    January 5, 2016
    Date of Event
    December 16, 2015
    Report Date
    December 16, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    PK102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED /EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW - PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: 16 OCTOBER 2015. EXPIRY DATE: 01 OCTOBER 2025. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE: 04.210.120 / 9910741 WAS MANUFACTURED IN US, (B)(4). MANUFACTURING DATE: 10/1/2015. LOT WAS RELEASED TO THE WAREHOUSE ON 10/1/2015. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE, PART NUMBER 04.210.120S, LOT 9689513). TWO SCREWS, PART NUMBER 04.210.120S, LOT NUMBERS 9689513 AND 9709983 WERE RETURNED. BASED ON THE FACT THAT PART AND LOT NUMBERS ARE NOT ETCHED ON THE SCREWS IT WAS NOT POSSIBLE TO IDENTIFY THE LOT NUMBER ASSIGNMENT OF EACH SCREW. ONE SCREW SHOWS HEAD THREAD DAMAGE WHERE THE PITCHES ARE WORN OUT AND MATERIAL BECAME DEFORMED. THE OTHER SCREW SHOWS NO DAMAGE ON THE ANODIZED SURFACE WHICH LEADS TO THE CONCLUSION THAT THIS SCREW IS IN AN INTACT CONDITION. THE DEVICE HISTORY RECORD REVIEWS OF BOTH LOTS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION (AS PREVIOUSLY REPORTED). IT IS LIKELY THAT INSERTION OF THE SCREWS IN AN OVER-TILTED POSITION OR APPLIANCE OF TOO MUCH FORCE DURING INSERTION COULD HAVE LED TO THE DAMAGE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE HISTORY RECORD REVIEW FOR CONCOMITANT SCREW: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: AUGUST 12, 2013. NEITHER DEVIATION NOR ANY NON-CONFORMANCE REPORTS WERE MARKED IN THE DEVICE HISTORY RECORD. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A DISTAL RADIUS FRACTURE SURGERY WAS PERFORMED ON (B)(6) 2015. WHEN THE SURGEON INSERTED THE VARIABLE ANGLE (VA) LOCKING SCREW INTO THE MOST DISTAL VA LOCKING HOLE IN THE RADIAL COLUMN AND TRIED TO LOCK IT DURING THE SURGERY, THE REPORTED SCREW WAS NOT LOCKED AND PASSED THROUGH THE REPORTED PLATE. THEN, THE SURGEON TRIED TO USE ANOTHER VA LOCKING SCREW (SAME SIZE) WHICH ALSO DID NOT WORK. THE SURGEON LEFT THE HOLE WITHOUT A SCREW AND LOCKED SCREWS INTO THE OTHER HOLES OF THE PLATE AND DECIDED TO COMPLETE THE SURGERY AS THE SURGEON FELT ENOUGH FIXATION WAS ACHIEVED. SUFFICIENT FIXATION WAS CONFIRMED BY MOTION OF THE PATIENT'S HAND AND WRIST JOINTS UNDER THE IMAGE INTENSIFIER. THE SURGERY WAS PROLONGED BY 20 MINUTES. NO PATIENT HARM WAS REPORTED. THE SURGEON COMMENTED THAT THE SECOND DISTAL VA LOCKING HOLE IN THE RADIAL COLUMN WAS SOMETHING WRONG THOUGH THE SCREW WAS SUCCESSFULLY LOCKED. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    CONCOMITANT DEVICES REPORTED: SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 7); CORTEX SCREW (PART 402.878, LOT 8566042, QUANTITY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3724 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE PLATE,FIXATION,BONE HRS SYNTHES SELZACH 9689513

    Patients

    Seq Age Sex Outcome Treatment
    1