BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REAMER 4.5/6.5 L450 F/HIP SCR F/EXPERT

    MDR report key: 10211554 · Received June 30, 2020

    Report

    Report Number
    8030965-2020-04530
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    May 12, 2019
    Report Date
    May 14, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. H3, H4, H6: PART: 03.010.368, LOT: U221168, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: MARCH 02, 2015. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE TIP OF THE REAMER IS BROKEN OFF AS REPORTED. THE REAMER BROKE BETWEEN THE SECOND (Ø4.5) AND THE THIRD (Ø6.5) STEP, THE FIRST 25MM BROKEN OFF PORTION WAS NOT RETURNED (REMAINS IN THE PATIENT¿S BODY). DIMENSIONAL INSPECTION: BECAUSE OF THE DAMAGES, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. 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 IS IDENTIFIED IN CERTIFICATE OF CONFORMITY AND HARDNESS IS DOCUMENTED ACCORDING TO 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 A COMBINATION BETWEEN INTENSE USE, AGE (MORE THAN 4 YEARS), AND A MECHANICAL OVERLOAD DURING USE DID LEAD TO BREAKAGE OF THE DEVICE. IN GENERAL, WE WOULD LIKE TO DRAW YOUR ATTENTION ON PAGE 4 IN THE LEAFLET ¿IMPORTANT INFORMATION¿: CHECK INSTRUMENTS FOR SOUND SURFACES, AND CORRECT ADJUSTMENT AND FUNCTION. DO NOT USE SEVERELY DAMAGED INSTRUMENTS, INSTRUMENTS WITH UNRECOGNIZABLE MARKINGS, CORROSION, OR BLUNT CUTTING SURFACES. WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. 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.

    Description of Event or Problem · 0

    THE PROCEDURE OCCURRED ON (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A SYNTHES EMPLOYEE. 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 · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 A DRILL BIT BROKE DURING SURGERY. THERE WAS NO CHANGE TO THE PATIENT'S POST-OP CARE. THE BROKEN DRILL BIT REMAINS INSIDE THE BONE TO NOT CAUSE HARM TO THE PATIENT. ON MAY 2020, THE HOSPITAL REQUESTED THE NUMBER OF CASES WITH BROKEN DRILL BITS DURING SURGERY IN (B)(6) WITHIN THE LAST THREE (3) YEARS. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) REAMER Ø4.5/6.5 L450 F/HIP SCR F/EXPERT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678143 REAMER 4.5/6.5 L450 F/HIP SCR F/EXPERT REAMER HTO OBERDORF SYNTHES PRODUKTIONS GMBH U221168

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention