BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROLLEY SCREWDRIVER

    MDR report key: 13095866 · Received December 28, 2021

    Report

    Report Number
    8030965-2021-10498
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    December 14, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    07611819321076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THERE WAS NO DAMAGE OR DEFECTS WITH THE TROLLEY SCREWDRIVER. THE COMPONENTS WERE ABLE TO BE ASSEMBLED WITHOUT ISSUES. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE TROLLEY SCREWDRIVER WAS FOUND TO HAVE NO DAMAGE OR DEFECTS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 HISTORY LOT - PART # 03.625.001, LOT # 7930094, MANUFACTURING DATA: 02. SEP 2014, LOCATION: SYNTHES GMBH UMKIRCH. THE REVIEW WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER. DURING CONVERSATION WITH THE TEAM AND IT WAS DISCOVERED THAT THE SAME ISSUE WAS IDENTIFIED WITHIN A FORMER PRODUCT COMPLAINT (B)(4) . AS AN OUTCOME OF THE ASSOCIATED MANUFACTURING COMPLAINT INVESTIGATION THE NON-CONFORMANCE NR-0137360 WAS INITIATED. WITHIN THE NR TWO ACTIONS WERE IMPLEMENTED TO PREVENT THIS KIND OF ISSUE FOR THE FUTURE. AS THIS AFFECTED COMPONENT WERE/ARE PRODUCED FROM A SUPPLIER, THE ORDERING INFORMATION WAS UPDATED. AS A SECOND ACTION THERE WAS THE WORK PLAN UPDATED WITH THE INFORMATION TO TAKE SPECIAL ATTENTION TO THE AFFECTED FEATURE. THERE WAS ALSO AN ACTION FOR THE PARTS ON THE MARKET. 10 PCS WERE RETRIEVED AND SCRAPED. THOSE 10 PCS WERE REPLACED WITH NEW ONES. FURTHERMORE, THE DESIGN/DRAWING OF THE COMPONENT 60032209 SHAFT WAS UPDATED WITHIN DCR/DCO_135230 TO NARROW THE TOLERANCE OF THE WIRE EDM GEOMETRY AND TO IMPLEMENT GAGE INSPECTION BASED ON THE FEASIBILITY FEEDBACK FROM THE SUPPLIER.,PRODUCT CODE #: 03.625.001 , SYNTHES LOT #: 7930094, MANUFACTURING SITE: WERK VILLMERGEN LOGISTIK , RELEASE TO WAREHOUSE DATE:13JUN2012, SUPPLIER: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NON-STERILE ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H6: PART: 03.625.001. LOT: 7930094. MANUFACTURING DATA: SEPTEMBER 02, 2014. LOCATION: SYNTHES GMBH UMKIRCH THE REVIEW WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER. DURING CONVERSATION WITH THE TEAM AND IT WAS DISCOVERED THAT THE SAME ISSUE WAS IDENTIFIED WITHIN A FORMER PRODUCT COMPLAINT (B)(4). RELEVANT ACTIONS HAVE BEEN TAKEN TO ADDRESS THE ISSUE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR INVESTIGATION. A PHOTO INVESTIGATION WAS PERFORMED BASED ON THE RECEIVED IMAGE. THE IMAGE WAS REVIEWED AND THE COMPLAINT CONDITION IS NOT CONFIRMED. THERE ARE NO VISIBLE DEFECTS OR DAMAGE IN THE PHOTO PROVIDED THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. 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. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGE) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE TROLLEY SCREWDRIVER COULD NOT BE MOUNTED, THE SCREWDRIVER BECAME STUCK AT THE THREAD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) TROLLEY SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990929 TROLLEY SCREWDRIVER SCREWDRIVER HXX SYNTHES GMBH 7930094 07611819321076

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male