BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.0MM FLEXIBLE SHAFT 440MM

    MDR report key: 7300375 · Received February 27, 2018

    Report

    Report Number
    8030965-2018-51457
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Date of Event
    January 26, 2018
    Report Date
    January 31, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTO
    UDI-DI
    07611819022713
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART: 351.440, LOT: 5001544: MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 21. JULY 2003: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS PERFORMED. THE EVALUATION HAS SHOWN THAT THE COMPLETE FRONT PART OF THE FLEXIBLE SHAFT IS BROKEN OFF, THE PART WAS NOT SENT BACK FOR EVALUATION. THE FLEXIBLE SHAFT IS UNSCREWED AND DEFORMED AT THE FOREFRONT. DUE TO THIS DAMAGE AND THE MISSING PIECE, THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT THIS DEVICE WAS MANUFACTURED IN JULY 2003 ACCORDING TO THE SPECIFICATION, INCLUDING PASSED TORSION TEST. THE DEVICE WAS MADE WITH A LOT SIZE OF (B)(4) PIECES AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS PART- AND LOT COMBINATION. THESE FINDINGS, THE AGE AND THE USED OVERALL CONDITION SPEAK AGAINST A MANUFACTURING RELATED ISSUE. BASED ON THE PROVIDED INFORMATION AND WITHOUT THE MISSING FRONT PART WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS BREAKAGE. WE CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD DURING USE CAUSED THIS BREAKAGE. 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.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INITIAL REPORTER IS SYNTHES SALES CONSULTANT THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH LOCKING COMPRESSION PLATE (LCP) ON AN UNKNOWN DATE TO TREAT A PERIPROSTHETIC FRACTURE. THE PLATE BROKE POSTOPERATIVELY ON AN UNKNOWN DATE. THE FRACTURE FAILED TO HEAL AND THE PLATE BROKE IN SITU. THE SURGEON BELIEVES THE PLATE BREAKING IS DUE TO THE NON-UNION OF THE FRACTURE. DURING REVISION OF THE CEMENTED IMPLANT ON (B)(6) 2018, THE SURGEON WAS USING THE FLEXIBLE REAMER, HE HAS STATED THAT HE WAS USING A REAMING HEAD TOO LARGE FOR THE REAMING SHAFT AND HE BELIEVES THAT THIS CREATED TOO MUCH TORQUE WHICH RESULTED IN THE FLEXIBLE REAMER BREAKING. HE HAS STATED THAT THE REAMER AND REAMING HEAD HAVE ALL BEEN REMOVED FROM THE PATIENT AND THE OPERATION WAS COMPLETED. THIS REPORT ADDRESSES THE INTRAOPERATIVE FLEXIBLE REAMER BREAKAGE DURING REVISION SURGERY. THE POSTOPERATIVE PLATE BREAKAGE HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 8.0MM FLEXIBLE SHAFT THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141883 8.0MM FLEXIBLE SHAFT 440MM REAMER HTO OBERDORF SYNTHES PRODUKTIONS GMBH 5001544 07611819022713

    Patients

    Seq Age Sex Outcome Treatment
    1