BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRONG ARM

    MDR report key: 4162273 · Received October 10, 2014

    Report

    Report Number
    1719045-2014-10500
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXD
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS CONDUCTED. (B)(4). BASED ON THE UNKNOWN CAUSE AND THE SUPPLIER¿S EVALUATION, THIS COMPLAINT IS CONSIDERED UNCONFIRMED AND IS NOT RELATED TO THE MANUFACTURING PROCESS OR MATERIALS. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: A 03.816.800 STRONG ARM, LOT 6971212 WAS RECEIVED UNDAMAGED WITH MINOR COSMETIC SIGNS. THE INSIGHT LATERAL ACCESS SYSTEM IS A SURGICAL ACCESS SYSTEM INTENDED TO PROVIDE A MINIMALLY INVASIVE APPROACH TO THE THORACOLUMBAR SPINE. IT IS DESIGNED FOR NEEDS OF VARIOUS INDICATIONS AND/OR SURGICAL TECHNIQUES. PART 03.816.800 IS A STRONG ARM USED TO RIGIDLY MATE WITH FEATURES ON RETRACTOR BODY (03.816.001) WITH STRONG ARM CONNECTOR (03.816.801).THE DRAWING ASSOCIATED WITH THE PART WAS REVIEWED. THE DRAWING CALLS OUT THE APPROPRIATE DIMENSIONS, MATERIAL AND FINISHING PROCESSES FOR A SUCCESSFUL DESIGN. THE RETURNED STRONG ARM, 03.816.800 / LOT 6971212, WAS RECEIVED UNDAMAGED WITH MINOR COSMETIC SIGNS. NO DESIGN RELATED ISSUES WERE IDENTIFIED ON INSPECTING THE RETURNED PART. THE INSTRUMENT WILL NOT HOLD THE HAZARD OCCURRED ON THIS COMPLAINT, DUE TO MISHANDLING OR EXCESSIVE FORCE APPLIED. 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

    A SERVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE WERE NO ISSUES OR NONCONFORMANCES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.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

    IT WAS REPORTED THAT: DURING THE SURGERY, THE 'STRONG ARM' WOULD NOT HOLD THE RETRACTOR TIGHTLY ENOUGH TO HOLD BACK THE TISSUE BEING RETRACTED WITHOUT SLIDING A PROBLEM WITH A 'STRONG ARM' DEVICE DURING A LATERAL LUMBAR INTERBODY FUSION PROCEDURE, THE 'STRONG ARM" DEVICE ATTACHES TO THE OPERATING TABLE, AND THE INSIGHT LS RETRACTOR. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY SUCCESSFULLY WITHOUT USING ALTERNATE LIKE OR SIMILAR INSTRUMENTS. THE SURGERY WAS PROLONGED BY 45 MINS TO ONE HOUR DUE TO THE COMPLAINED EVENT. THE PATIENT'S STATUS/ OUTCOME FOLLOWING THE SURGERY WAS REPORTEDLY GOOD. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640070 STRONG ARM CLAMP HXD SYNTHES MONUMENT 6971212

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention