BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90° SCREWDRIVER

    MDR report key: 8599523 · Received May 10, 2019

    Report

    Report Number
    8030965-2019-63757
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 10, 2019
    Report Date
    April 10, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HXX
    UDI-DI
    07611819187474
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H10 ADDITIONAL NARRATIVE: H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.505.003. LOT: 8181307. MANUFACTURING SITE: SELZACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 27.SEPTEMBER 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE RECEIVED SHAFT FOR SCREWDRIVER 90° SHOWS THAT THE GEAR ON THE DRIVER SHAFT IS BROKEN OFF AS COMPLAINED. OTHERWISE, THE INSTRUMENT IS IN GOOD CONDITION, BESIDES SOME SCRATCHES AND USAGE SIGNS. DIMENSIONAL INSPECTION: BECAUSE OF THE DAMAGES, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED TO PRINT SPECIFICATIONS ANYMORE. 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. THE USED MATERIAL WAS STAINLESS STEEL AS REQUIRED AND THE MEASURED HARNESS WAS WITHIN THE SPECIFICATION. SUMMARY: THE RECEIVED CONDITION OF THE DEVICE IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. WE ONLY CAN ASSUME THAT APPLIED MECHANICAL FORCES DURING USE CAUSED THIS BREAKAGE. IN THIS CONTEXT WE WOULD LIKE TO DRAW YOUR ATTENTION ON THE CURRENT TECHNIQUE GUIDE 036.001.596 ON PAGE 4: THESE DEVICES CAN BREAK DURING USE (WHEN SUBJECTED TO EXCESSIVE FORCES OR OUTSIDE THE RECOMMENDED SURGICAL TECHNIQUE). WHILE THE SURGEON MUST MAKE THE FINAL DECISION ON REMOVAL OF THE BROKEN PART BASED ON ASSOCIATED RISK IN DOING SO, WE RECOMMEND THAT WHENEVER POSSIBLE AND PRACTICAL FOR THE INDIVIDUAL PATIENT, THE BROKEN PART SHOULD BE REMOVED. THEREFORE, WE CAN CONFIRM THE VISIBLE DAMAGES ARE NOT FROM ANY MANUFACTURING NON-CONFORMITY. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. H11 CORRECTED DATA. B4; D4: LOT NUMBER. G4: THE INCORRECT G4 DATE WAS INADVERTENTLY UTILIZED IN INITIAL MEDWATCH. THE CORRECT DATE IS APRIL 10, 2019.  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 PRODUCT CODES DZI, DZJ. THE DEVICE WAS 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.

    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) 2019, DURING A HARDWARE REMOVAL PROCEDURE, THE SHAFT FOR SCREWDRIVER WAS BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO BROKEN PARTS LEFT IN THE PATIENT'S BODY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. PATIENT OUTCOME IS STABLE. 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
    392819 SHAFT FOR 90° SCREWDRIVER SCREWDRIVERS HXX OBERDORF SYNTHES PRODUKTIONS GMBH 8181307 07611819187474

    Patients

    Seq Age Sex Outcome Treatment
    1