BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX ARM

    MDR report key: 7472797 · Received April 30, 2018

    Report

    Report Number
    8030965-2018-53446
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Date of Event
    April 10, 2018
    Report Date
    April 10, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819376403
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. DEVICE HISTORY RECORD (DHR) REVIEW: PART NUMBER: 03.612.010; SYNTHES LOT NUMBER: H212060; SUPPLIER LOT NUMBER: H212060; RELEASE TO WAREHOUSE DATE: 01-FEB-2017; SUPPLIER: MEDIFLEX SURGICAL PRODUCTS; NO NCRS WERE GENERATED DURING PRODUCTION. 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. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SUPPLIER INVESTIGATION SUMMARY: SUPPLIER: MEDIFLEX PER THE ATTACHED SUPPLIER PRODUCT INVESTIGATION; THE INVESTIGATOR AT MEDIFLEX WAS ABLE TO DETERMINE THAT THE DEVICE WAS NOT OPERATING AS INTENDED. COMPONENT 69580-SYN-5 (STARBURST BODY) EXHIBITED STRIPPED THREADS DUE TO EXCESSIVE FORCE PREVENTING COMPONENT 65052-SYN (WING KNOB) TO FREELY ENGAGE WITH ITS COUNTERPART. ADDITIONALLY, A REVIEW OF THE DHR SHOWS THAT THE DEVICE WAS MANUFACTURED AND INSPECTED TO SPECIFICATION AND FUNCTIONED AS INTENDED UPON DEPARTURE FROM MEDIFLEX AS SHOWN ON THE ATTACHED DOCUMENTATION. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. 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 NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. (B)(4). 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 PATIENT UNDERWENT A PROCEDURE FOR LOWER BACK PAIN ON (B)(6) 2018 UTILIZING THE INSIGHT ACCESS RETRACTOR SYSTEM. DURING THE PROCEDURE, SURGEON WAS NOT ABLE TO CONNECT THE FLEX ARM BRIDGE TO THE FLEX ARM, AS THE SCREW ON THE FLEX ARM DID NOT TURN TO TIGHTEN THE FLEX ARM BRIDGE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 30 MINUTES. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. PATIENT STATUS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: SYNFRAME FLEX ARM BRIDGE (03.612.012, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) FLEX ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316778 FLEX ARM MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH H212060 07611819376403

    Patients

    Seq Age Sex Outcome Treatment
    1