BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS-WRENCH F/ONE-STEP INSERT-TECHN

    MDR report key: 7544939 · Received May 25, 2018

    Report

    Report Number
    8030965-2018-53981
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Report Date
    May 8, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWA
    UDI-DI
    07611819022119
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH 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. DHR REVIEW WAS COMPLETED. PART: 338.300 , LOT: 9022687, MANUFACTURING SITE: HÄGENDORF , RELEASE TO WAREHOUSE DATE: 21.AUG.2014 . THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. INVESTIGATION SELECTION , INVESTIGATION SITE: CQ ZUCHWIL , SELECTED FLOW: 5. BROKEN . VISUAL INSPECTION: THE VISUAL INSPECTION HAS SHOWN THAT THE INSTRUMENT IS BROKEN AT THE WELD SEAM INTO TWO PARTS. THE ITEM IS ALL IN ALL IN GOOD CONDITION AND SHOWS NO SIGNS OF MISUSE. DIMENSIONAL INSPECTION: MEASUREMENT OUTER DIAMETER Ø7.1:. GAGE: 3-03-17585 , TOLERANCE Ø7.1 0/-0.05 , RESULT: Ø7.06 "PASS". DRAWING/SPECIFICATION REVIEW: THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE, THEREFORE NO DRAWING/SPECIFICATION REVIEW IS NEEDED. MATERIAL REVIEW: THE MATERIAL WAS REVIEWED AND WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. SUMMARY: THE RECEIVED CONDITION OF THE RETURNED INSTRUMENT IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. THIS LOT OF (B)(4) PIECES WAS MANUFACTURED IN AUGUST 2014 ACCORDING TO THE SPECIFICATION. THE SUB-COMPONENT 50101706 IS NOT LOT TRACKED. THEREFORE THE LAST THREE POTENTIAL WORK ORDERS THAT WERE PRODUCED PRIOR TO LOT 9090695 WERE REVIEWED. THE REVIEW HAS SHOWN THAT WITH 1.4301 THE CORRECT MATERIAL WAS USED. BASED ON THAT AND THE CONDITION OF THE ITEM A PRODUCT RELATED ISSUE CAN BE EXCLUDED. A 100% TIGHTENING TORQUE TEST WAS PERFORMED AFTER THE WELDING PROCEDURE WITH A TORQUE OF 5NM AND ALL THE PARTS PAST THE TEST. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LEAD TO THIS OCCURRENCE. WE ONLY CAN ASSUME THAT A MECHANICAL OVERLOADING SITUATION HAS CAUSED THE BREAKAGE. 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 · 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. MFR SITE: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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

    PATIENT INFORMATION IS UNKNOWN. DATE OF EVENT WAS REPORTED AS THE (B)(6) DAY, 2018. MONTH IS UNKNOWN. LOT NUMBER IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DHS IMPACTOR AND SCREW BROKE DURING SURGERY. NEW INSTRUMENTS WERE USED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A DHS®/DCS® IMPACTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387905 DHS/DCS-WRENCH F/ONE-STEP INSERT-TECHN IMPACTOR HWA OBERDORF SYNTHES PRODUKTIONS GMBH 9022678 07611819022119

    Patients

    Seq Age Sex Outcome Treatment
    1