BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRUCIFORM SCREWDRIVER

    MDR report key: 9238274 · Received October 25, 2019

    Report

    Report Number
    2939274-2019-61745
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Report Date
    October 8, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587037189
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED IN A VETERINARY CASE - NO PATIENT INFORMATION WILL BE REPORTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE 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 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

    PRODUCT COMPLAINT # (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT: PART: 313.960; LOT: 1940152; MANUFACTURING SITE: (B)(4); RELEASE TO WAREHOUSE DATE: 07. JULY 2008. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY BACKGROUND: VETERINARY COMPLAINT: IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE THE SURGEON WAS PERFORMING A 2.4 TIBIAL-PLATEAU-LEVELING OSTEOTOMY (TPLO) AND TIGHTENING A CORTEX SCREW, THE TIP OF THE CRUCIFORM SCREWDRIVER SHEARED OFF THE DRIVER. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE AND WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY REPORTED WITH AN UNKNOWN NUMBER OF MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN UNKNOWN PERIOSTEAL ELEVATOR. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CORTEX SCREW ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) AND UNKNOWN TPLO PLATE ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) THIS COMPLAINT INVOLVES ONE (1) DEVICE. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: CRUCIFORM SCREWDRIVER WAS RECEIVED AT US (B)(4). UPON VISUAL INSPECTION AT (B)(4), IT IS OBSERVED THAT DISTAL TIP OF THE DEVICE WAS BROKEN. THE BROKEN FRAGMENTS WERE NOT RECEIVED AT US CQ. THE REST OF THE DEVICE SHOWS NORMAL WEAR CONSISTENT WITH THE DEVICE USE WHICH WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. THUS, THE COMPLAINT IS BEING CONFIRMED. NO DESIGN ISSUES WERE FOUND WHICH CAN CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION CONCLUSION: A VISUAL INSPECTION, DIMENSIONAL INSPECTION, AND DOCUMENT/SPECIFICATION REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS BEING CONFIRMED AS THE DISTAL TIP OF THE DEVICE WAS BROKEN. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED PROBLEM, IT IS POSSIBLE THAT THE DEVICE MIGHT HAVE ENCOUNTERED UNINTENDED FORCES. NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED, AND NO NEW MALFUNCTIONS WERE IDENTIFIED EITHER. BASED UPON THESE RESULTS, NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE THE SURGEON WAS PERFORMING A 2.4 TIBIAL-PLATEAU-LEVELING OSTEOTOMY (TPLO) AND TIGHTENING A CORTEX SCREW, THE TIP OF THE CRUCIFORM SCREWDRIVER SHEARED OFF THE DRIVER. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE AND WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY REPORTED WITH AN UNKNOWN NUMBER OF MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN UNKNOWN PERIOSTEAL ELEVATOR. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE: UNKNOWN CORTEX SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN TPLO PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033610 CRUCIFORM SCREWDRIVER SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 313.96 1940152 10887587037189

    Patients

    Seq Age Sex Outcome Treatment
    1