BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE

    MDR report key: 8638638 · Received May 23, 2019

    Report

    Report Number
    8030965-2019-64498
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Report Date
    April 25, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    FZX
    UDI-DI
    07611819163454
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. INVESTIGATION SUMMARY: THE LCP DRILL SLEEVE IS BROKEN OFF AS COMPLAINED. THE DRILL SLEEVE IS IN A USED CONDITION WITH SLIGHT DAMAGES INSIDE THE SLEEVE.BECAUSE OF THE DAMAGES THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED TO PRINT SPECIFICATIONS ANYMORE. HOWEVER THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS. THE USED MATERIAL WAS 1.4123, AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. THE RECEIVED CONDITION AGREE WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT THEREFORE IS CONFIRMED. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. THE EXACT ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED BUT THE MOST PROBABLE REASON IS MECHANICAL OVERLOADING. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS APPROPRIATE. DEVICE HISTORY REVIEW: PART: 323.061. LOT: 8872045. MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: 07.MAR.2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE SUB-COMPONENT 50152678 IS NOT LOT TRACKED. THEREFORE THE LAST THREE POTENTIAL WORK ORDERS (8956750, 8952020 AND 8952022) THAT WERE PRODUCED PRIOR TO LOT 8872045 WERE REVIEWED. THE REVIEW HAS SHOWN THAT WITH 1.4123 THE CORRECT MATERIAL WAS USED AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION OF 56 +4/0 HRC FROM DRAWING 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

    REPORTER IS A SYNTHES EMPLOYEE. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE LOCKING COMPRESSION PLATE (LCP) DRILL SLEEVE AND DRILL BIT WERE BROKEN DURING DRILLING. PATIENT CONDITION AND SURGICAL OUTCOME ARE UNKNOWN. THIS REPORT IS FOR A 2.0 MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429341 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE GUIDE FZX OBERDORF SYNTHES PRODUKTIONS GMBH 8872045 07611819163454

    Patients

    Seq Age Sex Outcome Treatment
    1