BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 10563332 · Received September 21, 2020

    Report

    Report Number
    8030965-2020-07275
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    August 26, 2020
    Report Date
    August 26, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTO
    UDI-DI
    07611819243668
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    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. VISUAL INSPECTION: THE VISUAL INSPECTION HAS SHOWN THAT THE SYNREAM FLEXSHAFT IS BROKEN OFF AS COMPLAINED. IN GENERAL THE SYNREAM FLEXSHAFT IS IN A VERY USED CONDITION. THERE ARE CLEARLY VISIBLE STRESS MARKS ALL OVER THE INSTRUMENT. DIMENSIONAL INSPECTION: CHECKED DIMENSIONS WITH CALIPER 3-01-20766 PER DRAWING D0011220 VERSION 01 (TUBE, ART. NO. 507560) OUTER DIAMETER SPECIFICATION / MEASURED: = PASS. DRAWING/SPECIFICATION REVIEW: DRAWING D0011185 VERSION 06 (FOR THE COMPLETE FLEXSHAFT) AND D0011220 VERSION 01 (TUBE, ART. NO. 507560, NITINOL BB) WAS REVIEWED DURING THE EVALUATION TO VERIFY THE MEASUREMENTS AND MATERIAL. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT THE CORRECT MATERIAL WAS USED. SUMMARY THE COMPLAINT CONDITION IS CONFIRMED AS THE SYNREAM FLEXSHAFT IS BROKEN OFF AS COMPLAINED. THIS PRODUCTION LOT (2283015) WAS MANUFACTURED IN JULY 2007. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITY REPORTED. THE INVESTIGATION FOUND NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. THE DAMAGE OCCURRED IS DETERMINED TO BE POST PRODUCTION/ACCEPTANCE CRITERIA. A DEFINITIVE ROOT CAUSE FOR THE BREAKAGE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION, HOWEVER THIS COMPLAINT CONDITION IS MOST LIKELY DUE TO EXCESSIVE APPLIED FORCE/STRAIN. 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. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT PART NUMBER: 352.040, LOT NUMBER: 2283015, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: JULY 12, 2007 . A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES 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

    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 (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS REAMING THE FEMORAL CANAL WHEN THE REAMER SHAFT BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER REAMER SET. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 5.0MM FLEXIBLE SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024412 5.0MM FLEXIBLE SHAFT REAMER HTO OBERDORF SYNTHES PRODUKTIONS GMBH 2283015 07611819243668

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR