BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRONG ARM

    MDR report key: 6059393 · Received October 26, 2016

    Report

    Report Number
    1719045-2016-10786
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 6, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDERGOING INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE PENDING COMPLETION. A DEVICE HISTORY RECORD REVIEW 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION RESULTS ARE AS FOLLOWS. THE RETURNED STRONG ARM WAS EXAMINED AND THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED. THE STRONG ARM WAS FOUND TO TENSION AS INTENDED AND FORM A RIGID CONSTRUCT AND NO BREAKAGE WAS NOTED. ADDITIONALLY THE RETURNED RETRACTOR BODY AND STRONG ARM CONNECTOR WERE FOUND TO ATTACH TO THE COUPLING END OF THE STRONG ARM AS INTENDED. AS THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED AND NO DEFECTS OF DEFICIENCIES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT CONDITION, NO FURTHER INVESTIGATION INCLUDING OCCURRENCE RATE CALCULATION AND RISK ASSESSMENT REVIEW WILL BE COMPLETED. A VISUAL INSPECTION, FUNCTIONAL TEST AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. 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. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER 9875129. MANUFACTURING LOCATION: (B)(4). DATE OF MANUFACTURE: JAN 13, 2016. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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

    DESCRIBE EVENT OR PROBLEM: ADDITIONAL UPDATED INFORMATION PROVIDED FOR REPORTING. DEVICE 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 ON (B)(6) 2016, DURING A LATERAL APPROACH L2-L3 CORPECTOMY PROCEDURE, THE INSIGHT L RETRACTOR INSTRUMENT ASSEMBLY WAS LOOSE AND REQUIRED CONSTANT ADJUSTMENTS FOR STABILITY. IT WAS REPORTED THAT DURING THE PROCEDURE, AS THE SURGEON WAS PLACING THE RETRACTOR BODY ONTO THE RIDGED STRONG ARM WITH THE CONNECTOR INSTRUMENTS, THE ASSEMBLY WAS LOOSE AND NEEDED CONSTANT ADJUSTMENTS FOR STABILITY. ADDITIONAL X-RAYS WERE NEEDED FOR CORRECT PLACEMENT. THE SURGEON HAD ISSUES WITH THE STRONG ARM INSTRUMENT FROM THE BEGINNING TO THE END OF THE PROCEDURE. THE REPORTED EVENT RESULTED IN A ONE HOUR SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT'S POSTOPERATIVE CONDITION WAS REPORTEDLY STABLE. AFTER SURGERY IS WAS OBSERVED THAT THE WELD HAD COME LOOSE ON THE STRONG ARM INSTRUMENT. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD A SPINAL INFECTION FROM A PREVIOUS UNKNOWN SURGERY PERFORMED ON AN UNKNOWN DATE IN 2016. THERE WERE NO DEVICES IMPLANTED DURING THE PREVIOUS SURGERY. DURING THE (B)(6) 2016 PROCEDURE, THE PATIENT WAS REVISED WITH ALLOGRAFT STRUT GRAFT, AND UNKNOWN COMPETITOR'S AND DEPUY EXPEDIUM IMPLANTS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE INFORMATION: 10/25/2016 CONCOMITANT DEVICES REPORTED: RETRACTOR BODY (ITEM # 03.816.001 LOT # 9345909, QTY. 1 EACH), STRONG ARM CONNECTOR (ITEM # 03.816.801, LOT # 8915551, QTY. 1 EACH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708545 STRONG ARM CLAMP HXD SYNTHES MONUMENT 9875129

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 03.816.001, RETRACTOR BODY| 03.816.801, STRONG ARM CONNECTOR