BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16MM CANNULATED HOLLOW DRILL BIT

    MDR report key: 7517605 · Received May 16, 2018

    Report

    Report Number
    8030965-2018-53779
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Report Date
    April 25, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819642317
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. PATIENT ETHNICITY IS UNKNOWN. ADDED REPORT SOURCE - FOREIGN PART: 03.037.004; SYNTHES LOT: 160236-101; MANUFACTURING LOCATION: SELZACH; SUPPLIER: LEITNER AG; RELEASE TO WAREHOUSE DATE: SEPTEMBER 02, 2016; NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SITE: CQ ZUCHWIL; SELECTED FLOW: BROKEN VISUAL INVESTIGATION: THE POSITIONING SPRING ON THE CENTERING ATTACHMENT BODY FOR THE HOLLOW REAMER D16MM CANNULATED IS MISSING AS COMPLAINED BECAUSE THE LASER WELD BROKE. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION IS NOT APPROPRIATE AS THE COMPLAINT CAUSE IS THE BROKEN LASER WELD ON THE MISSING POSITIONING SPRING. DRAWING/SPECIFICATION REVIEW: THE CAUSE OF THE COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED BREAKAGE/DAMAGE AT THE DEVICE, THEREFORE NO DRAWING/SPECIFICATION REVIEW IS NEEDED. SUMMARY: THE RECEIVED CONDITION AGREES WITH THE COMPLAINT DESCRIPTION; THE COMPLAINT IS THEREFORE CONFIRMED. THE DAMAGED DEVICE WAS FOUND BROKEN IN A LOAN SET AND NO ADDITIONAL INFORMATION ABOUT THE EVENT WAS PROVIDED. THE BORE IN THE CENTERING ATTACHMENT BODY FOR THE HOLLOW REAMER D16MM CANNULATED SHOWS THE REMAINING LASER WELD WHICH SHOWS THAT THE LASER WELDING STEP WAS CONDUCTED DURING MANUFACTURING. A MANUFACTURING CONCLUSION CANNOT BE DETERMINED AS THE SMALL SPRING, MEASURING ONLY 1MM IN DIAMETER, WAS NOT RECEIVED FOR INVESTIGATION. FURTHERMORE, NO INFORMATION COULD BE OBTAINED ABOUT WHEN AND WHERE THE DAMAGE OCCURRED. THE DHR REVIEW SHOWS THAT THE DEVICE FULLY MET OUR SPECIFICATIONS AT THE TIME OF MANUFACTURING IN SEPTEMBER 2016 AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT HISTORY REVIEW DID NOT DETECT SIMILAR COMPLAINTS OF THIS ARTICLE. WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT BUT WE SUPPOSE THAT A MECHANICAL OVERLOADING SITUATION LED TO THE BREAKAGE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. CONCLUSION CODES: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT. 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 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. A DEVICE HISTORY RECORD REVIEW WAS REQUESTED. 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.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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: IT WAS REPORTED THAT THE HOLLOW REAMER WAS FOUND BROKEN AFTER UNPACKED FROM J&J LOANED. IT IS NOT KNOWN IF A PATIENT WAS INVOLVED. THIS IS ALL INFORMATION WE HAVE SO FAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363285 16MM CANNULATED HOLLOW DRILL BIT MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH 160236-101 07611819642317

    Patients

    Seq Age Sex Outcome Treatment
    1