BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED CRUCIFORM SCREWDRIVER

    MDR report key: 10025074 · Received May 5, 2020

    Report

    Report Number
    8030965-2020-03293
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Report Date
    April 22, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HXX
    UDI-DI
    07611819710894
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: MANUFACTURING LOCATION: SUPPLIER - FLEXTRONICS AMERICA LLC / INSPECTED, PACKAGED AND RELEASED BY: MONUMENT RELEASE TO WAREHOUSE DATE: AUGUST 11, 2016 PART: 314.463, CANNULATED CRUCIFORM SCREWDRIVER, LOT: 9972967 (NON-STERILE). PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF COMPLIANCE SUPPLIED TO FLEXTRONICS BY AVALIGN WAS REVIEWED AND DETERMINED TO BE CONFORMING. HARDNESS WAS CERTIFIED WITHIN SPECIFICATION. CERTIFICATE INDICATES THAT THE LOT WAS ACCEPTED BY FLEXTRONICS. INSPECTION SHEET, INCOMING FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE INSPECTION HAS SHOWN THAT TWO OF THE FOUR SCREW HOLDING TABS OF THE CANNULATED SCREWDRIVER ARE BROKEN OFF. THE BROKEN OFF TAB WERE NOT RETURNED FOR EVALUATION. BESIDES, THE INSTRUMENT IS IN GOOD CONDITION. ALL FEATURES RELATED TO THE REPORTED COMPLAINT CONDITION WERE REVIEWED AND NO OTHER ISSUES WERE IDENTIFIED. DIMENSIONAL INSPECTION: THE RELEVANT DIMENSIONS CANNOT BE VERIFIED DUE TO DAMAGE INCURRED AND DUE TO THE MISSING PART. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DURING THE DEVICE HISTORY RECORD (DHR) REVIEW, THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION. SUMMARY: THE OBSERVED DAMAGE IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION AS SUCH THE COMPLAINT CONDITION CAN BE CONFIRMED. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DAMAGE OCCURRED IS DETERMINED TO BE POST PRODUCTION/ACCEPTANCE CRITERIA. A DEFINITIVE ROOT CAUSE FOR THE GIVEN COMPLAINT CONDITION COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. HOWEVER, IT IS MOST LIKELY THAT ANY UNINTENDED EXCESSIVE FORCES DURING USAGE SUCH AS PROVIDING TORQUE WITH IMPROPER ALIGNMENT COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: VETERINARY REPORT: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE TOOTH (AT THE EXTREMITY) OF THE SCREWDRIVER BROKE. NO FRAGMENTS REMAINED IN THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THE SCREWDRIVER HAD RECEIVED PREVIOUS LITTLE USE AND WAS PURCHASED IN (B)(6) 2016. THIS REPORT IS FOR A CANNULATED CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488858 CANNULATED CRUCIFORM SCREWDRIVER SCREWDRIVERS HXX OBERDORF SYNTHES PRODUKTIONS GMBH 9972967 07611819710894

    Patients

    Seq Age Sex Outcome Treatment
    1