BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX ARM

    MDR report key: 7252312 · Received February 8, 2018

    Report

    Report Number
    8030965-2018-50962
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    January 17, 2018
    Report Date
    January 17, 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 03.612.010, SYNTHES LOT NUMBER: 9833185, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: 22-JAN-2016, 18-FEB-2016, EXPIRATION DATE: N/A, SUPPLIER: MEDIFLEX SURGICAL PRODUCTS. NCR #NR-0026043 WAS GENERATED DURING PRODUCTION FOR 50 PARTS WITH CE MARK NOT PRESENT. PARTS WERE RETURNED TO VENDOR. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION SINCE IT IS NOT RELATED TO THE COMPLAINT EVENT. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS PERFORMED. THIS COMPLAINT IS CONFIRMED. RETURNED FLEX ARM (PART# 03.612.010, LOT# 9833185) DID NOT OPERATE AS INTENDED AT MEDIFLEX. IT APPEARS THAT THE DEVICE WAS TIGHTENED USING EXCESSIVE FORCE WHICH LEAD TO THE DEFORMATION OF COMPONENT 80057-416 (DRAWBAR) AND FORCED IT INTO COMPONENT 69580-SYN-6 (LINK 3/4") RENDERING THE DEVICE UNUSABLE. SEE ATTACHED FILE TITLED "(B)(4) MANUFACTURING INVESTIGATION" FOR FULL DETAILS OF SUPPLIER MEDIFLEX INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 · 0

    LEGAL MANUFACTURER. DATE RECEIVED AT FINAL DESTINATION. 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE SPINE SURGERY FOR DECOMPRESSION WAS PERFORMED BY USING THE INSIGHT RETRACTOR. WHEN THE DIAL WAS TURNED INTO THE ¿FIX¿ DIRECTION FOR THE FLEX ARM TO FIX THE RETRACTOR, THE FLEX ARM COULD NOT BE FIXED. FOR THAT REASON, THE RETRACTOR COULD NOT BE USED, AND THE OTHER DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A TEN (10) MINUTE DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99070 FLEX ARM MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH 9833185 07611819376403

    Patients

    Seq Age Sex Outcome Treatment
    1