BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS-SCR Ø12.5 L100 SST

    MDR report key: 9251962 · Received October 29, 2019

    Report

    Report Number
    8030965-2019-69781
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    October 8, 2019
    Report Date
    October 11, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819012547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE. INVESTIGATION SUMMARY: INVESTIGATION SITE: CQ ZUCHWIL. SELECTED FLOW: DEVICE INTERACTION: UNABLE TO ASSEMBLE. VISUAL INSPECTION: THE DHS/DCS® SCREW WAS RECEIVED WITH THE REPORTED CONDITION OF VISUAL - DAMAGED. THE VISUAL INSPECTION HAS SHOWN THAT THE POSITIONING GROOVE OF THE DHS/DCS® SCREW IS EXPANDED AND DAMAGED. DIMENSIONAL INSPECTION CHECKED DIMENSIONS WITH CALIPER 3-01-20766 PER DRAWING FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE DAMAGE INCURRED. DOCUMENT / SPECIFICATION REVIEW: THE RETURNED DHS/DCS SCREW WAS MANUFACTURED IN SEPTEMBER 2016 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS. THE RELEVANT FEATURE (FLAT SURFACE DISTANCE) WAS RANDOMLY INSPECTED BEFORE THE PART LEFT MANUFACTURING SITE (INSPECTION SHEET SE_441329, REV AO). CONSEQUENTLY, THE DAMAGE OCCURRED IS DETERMINED TO BE POST PRODUCTION/ACCEPTANCE CRITERIA. SUMMARY: THE INVESTIGATION OF THE DHS/DCS SCREW HAS SHOWN THAT THE POSITIONING GROOVE OF THE SCREW IS DAMAGED AND WIDENED UP, THIS DAMAGE PREVENTS THE INSERTION OF THE PLATE. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS IMPLANT WAS MANUFACTURED IN SEPTEMBER 2016 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITY REPORTED. THE RELEVANT DIMENSIONS AT THE UNDAMAGED AREA WERE CHECKED, AND NO DEVIATION WAS DETECTED. THE DAMAGE OCCURRED IS DETERMINED TO BE POST-MANUFACTURING. THE TYPE AND EXTENT OF DAMAGE INCURRED INDICATES THAT THE POSITIONING GROOVE HAS BEEN WIDENED UP DUE TO INADEQUATE HANDLING. IN ORDER TO ENSURE A CORRECT LOAD TRANSFER IT IS CRUCIAL TO HAVE AN APPROPRIATE CONNECTION BETWEEN THE DHS-SCREW AND THE CONNECTING SCREW 338.310, WHICH IS GUIDED THROUGH THE APPROPRIATE DHS/DCS WRENCH. (SURGICAL TECHNIQUE 036.000.255 DSEM/TRM/1114/0221). BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT: PART NUMBER: 280.000S. LOT NUMBER: L114132. MANUFACTURING SITE: BALSTHAL. RELEASE TO WAREHOUSE DATE: SEP 01, 2016. EXPIRY DATE: AUG 01, 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE 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 · 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 SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A DHS SCREW DID NOT FIT IN THE DHS PLATE AFTER HANDLING IT CORRECTLY. NO PATIENT CONSEQUENCE. THIS IS 1 OF 2 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047236 DHS/DCS-SCR Ø12.5 L100 SST APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L114132 07611819012547

    Patients

    Seq Age Sex Outcome Treatment
    1