BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    MDR report key: 7642827 · Received June 27, 2018

    Report

    Report Number
    8030965-2018-54671
    Event Type
    Malfunction
    Date Received
    June 27, 2018
    Report Date
    June 5, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTO
    UDI-DI
    07611819739208
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR ITEM: 314.743, LOT: 9895470: REC'D QTY: 93, REC'D DATE: 29 FEB 2016, MANUFACTURER: CRITERION TOOL & DIE, INC. WITH INSPECTION & PACKAGING IN MONUMENT: REQUIRED INSPECTIONS WERE PERFORMED AND PASSED PER CERTIFICATE OF COMPLIANCE PROVIDED BY CRITERION CERTIFYING THAT PRODUCT WAS MANUFACTURED TO THE MATERIAL AND CUSTOMER AND/OR INDUSTRY SPECIFICATIONS INDICATED ON THE DRAWING AND PURCHASE ORDER. THERE WERE NO NCS OR REWORKS NOTED WITHIN THE DHR. NO NON-CONFORMANCE 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. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE DEVICE (PART # 314.743, LOT # 9895470) WAS RECEIVED AT US CQ WITH ONE MEDIAL BREAK IN THE DRIVE SHAFT AND MISSING A FRAGMENT WHICH LIKELY WAS SUCTIONED AWAY. NO NEW ISSUES WERE IDENTIFIED WITH THE REMAINING PORTIONS OF THE DEVICE, THE DISTAL TIP WAS FULLY INTACT. THE BROKEN DEVICE AGREES WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT IS CONFIRMED. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS COMPLETED, THE OUTER DIAMETER OF THE SHAFT WAS MEASURED AND IS WITHIN THE SPECIFICATION PER RELEVANT DRAWING. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE 29 FEB 2016 THE RELEVANT DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS THE DEVICE (PART # 314.743, LOT #9895470) WAS RECEIVED WITH A BROKEN SHAFT. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES (SUCH AS BEING DROPPED, STRUCK OFF AXIS OR DAMAGED DURING STERILE PROCESSING). NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 WAS NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODE: HRX. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. 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

    ADDITIONAL NARRATIVE: DATE DEVICE RECEIVED BY MANUFACTURER. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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 ON AN UNKNOWN DATE, THE FLEXIBLE SHAFT BROKE IN DIFFERENT POINTS DURING SURGERY. NO ADVERSE EVENT TO THE PATIENT REPORTED. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484768 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO OBERDORF SYNTHES PRODUKTIONS GMBH 9895470 07611819739208

    Patients

    Seq Age Sex Outcome Treatment
    1