BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90° SCREWDRIVER

    MDR report key: 8105948 · Received November 27, 2018

    Report

    Report Number
    2939274-2018-55105
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Report Date
    November 7, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    DZI
    UDI-DI
    10887587013299
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 03.505.003, LOT: 8150502. MANUFACTURING LOCATION: SELZACH, RELEASE TO WAREHOUSE DATE: JUN 08, 2015. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION WAS COMPLETED. THE SHAFT FOR THE 90-DEGREE SCREWDRIVER RECEIVED WAS OBSERVED WITH DAMAGED DISTAL COUPLING END ON ITS GEAR SHAFT. THE COUPLING END PORTION OF GEAR SHAFT WAS IDENTIFIED WITH NICKS AT ALL FOUR COUPLING TABS. FURTHERMORE, THE BEARING PROXIMAL TO GEAR SHAFT COUPLING WAS FOUND DISTORTED WITH NO BALL PORTIONS REMAINED ON THE BALL BEARING ASSEMBLY. ALL BALL PORTIONS OF THE BALL BEARING WERE NOT RETURNED. LASTLY, THE CASING THAT COVERS THE BALL BEARING UNIT WAS ALSO NOT RETURNED. WITH MISSING COMPONENTS, IT IS UNKNOWN IF BREAKAGE OCCURRED ON THOSE PORTIONS. THE GEAR SHAFT AND THE HOUSING SHAFT WITH GEAR COVER WERE RETURNED INTACT. NO FURTHER ISSUES SUCH AS BREAKAGE OF THE DEVICE WAS IDENTIFIED ON RETURNED PORTIONS OF THE DEVICE INCLUDING THE CONCOMITANT HOUSING SHAFT (PART: 03.505.003 LOT: 8151528). IT WAS DETERMINED THAT THE RECEIVED CONDITION DOES NOT AGREE WITH THE COMPLAINT DESCRIPTION FOR THIS DEVICE. HOWEVER, WITH THE DEFORMATION AND MISSING COMPONENT CONDITION IDENTIFIED ON THE RETURNED PORTIONS OF THE DEVICE, THE OVERALL COMPLAINT CONDITION WAS CONFIRMED. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WAS REVIEWED DURING THE INVESTIGATION. DIMENSIONAL INSPECTION AT RELEVANT PORTIONS WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE ON THE COUPLING TABS AND BEARING ASSEMBLY. FURTHERMORE, DIMENSIONAL ANALYSIS ON THE DAMAGED BALL BEARING AND ITS CASING IS NOT POSSIBLE DUE TO MISSING COMPONENT CONDITIONS. DURING THE INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE OVERALL COMPLAINT CONDITION WAS CONFIRMED. HOWEVER, NO DESIGN OR MANUFACTURING DEFECT OR DEFICIENCY WAS OBSERVED DURING THE INVESTIGATION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN AND THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT 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 · 0

    CONCOMITANT DEVICE: SHAFT FOR SCREWDRIVER: (PART 03.505.003, LOT 8151528, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODES: DZJ, HXX. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. 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 DURING AN OPEN REDUCTION INTERNAL FIXATION RIB CASE PROCEDURE ON (B)(6) 2018, THE 90-DEGREE SCREWDRIVER WAS SPINNING SLOW. AFTER THE PRODUCT WAS CLEANED, THE SURGEON NOTICED THAT THE DRIVE SHAFT WAS BROKEN. AN ALTERNATIVE SHAFT FOR 90-DEGREE SCREWDRIVER IN THE SET WAS USED, SPUN AT A NORMAL SPEED, AND WAS ABLE TO DRILL. THERE WAS NO PATIENT CONSEQUENCE. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A SHAFT FOR 90-DEGREE SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944481 SHAFT FOR 90° SCREWDRIVER DRILL, BONE, POWERED DZI WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.505.003 8150502 10887587013299

    Patients

    Seq Age Sex Outcome Treatment
    1