BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90 SCREWDRIVER

    MDR report key: 10188158 · Received June 24, 2020

    Report

    Report Number
    8030965-2020-04382
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    June 4, 2020
    Report Date
    June 11, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    DZI
    UDI-DI
    07611819187474
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. H3, H4, H6: PART: 03.505.003, LOT: 8193393, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: DECEMBER 27, 2019. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE RETURNED SHAFT F/SCREWDRIVER 90° IS STILL IN A GOOD CONDITION WITH NO SIGNIFICANT DAMAGES OR DEFECT VISIBLE. FUNCTIONAL TEST: DURING THE DISSEMBLING OF THE SHAFT PARTS IT WAS DETECTED THAT AT THE UPPER CONNECTION SIDE AN SECURE PIN IS SHEAR OFF. THE DETECTED DAMAGE OF THE SHEARED PIN DID LEAD TO THE COMPLAINED MALFUNCTION: SCREWDRIVER STOPPED DURING USE. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW OF THE PARTS SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SUMMARY: THE RECEIVED CONDITION AGREE WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT THEREFORE IS CONFIRMED. THE INVESTIGATION HAS SHOWN THAT AT THE UPPER CONNECTION SIDE AN SECURE PIN IS SHEAR OFF. THE DETECTED DAMAGE OF THE SHEARED PIN DID LEAD TO THE COMPLAINED MALFUNCTION: SCREWDRIVER STOPPED DURING USE. THE PRESENT ARTICLES HAS SHOWN THAT IN THE SHAFT AS WELL IN THE SLEEVE IS THE SECURE PIN VISIBLE WHICH CONNECTED THE UPPER CONNECTION SIDE AS INTENDED. THE CONNECTION PART CONFORMED THE SPECIFICATION AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS.THESE INDICATION LED US ASSUME THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES, SUCH AS A MECHANICAL OVERLOAD DURING SURGERY, WHICH FINALLY CAUSED THE POST MANUFACTURING DAMAGES. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE ROOT CAUSE WAS IDENTIFIED DURING THE PERFORMED CQ EVALUATION AND THEREFORE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS "DIMENSIONAL INSPECTION:" ARE NOT REQUIRED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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

    ADDITIONAL PROCODE: DZJ, HXX. 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. PRODUCT WAS NOT RETURNED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A 90 DEGREE SCREWDRIVER STOPPED DURING USE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SHAFT FOR 90° SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651926 SHAFT FOR 90 SCREWDRIVER DRILL, BONE, POWERED DZI OBERDORF SYNTHES PRODUKTIONS GMBH 8193393 07611819187474

    Patients

    Seq Age Sex Outcome Treatment
    1