BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORACLE SLAP HAMMER

    MDR report key: 3458964 · Received November 8, 2013

    Report

    Report Number
    1719045-2013-02044
    Event Type
    Malfunction
    Date Received
    November 8, 2013
    Date of Event
    October 14, 2013
    Report Date
    October 14, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4)

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(6). A REVIEW OF SYNTHES DEVICE HISTORY RECORD FOR LOT 6552991 REVEALED THE ORACLE SLAP HAMMER WAS MANUFACTURED BY AVALIGN TECHNOLOGIES-NEMCOMED. PO 1223623, DATED 2/16/11, FOR 40 PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER NS027776 REV B ON 2/16/2011. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED 2/15/11. FORTY PARTS WERE RELEASED TO THE WAREHOUSE ON 2/17/11. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS REVIEWED BY MANUFACTURING: THE PRODUCT WAS RECEIVED IN THREE PIECES BECAUSE THE THREADS OF THE SHAFT BROKE OFF AND ALLOWS THE OTHER PARTS TO BE FREE. ALL OF THE PARTS APPEAR TO BE IN GOOD CONDITION OTHER THAN THE THREADS BEING BROKEN. DUE TO AN UNKNOWN CAUSE, THE TOP OF THE SLIDE CAME APART. THE MATERIAL OF THE HEAD AND SHAFT WAS DETERMINED TO BE WITHIN SPECIFICATION AND THE SHAFT HARDNESS WAS WITHIN SPECIFICATION. THE INSTRUMENT CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE DIAMETER OF THE SHAFT WAS CONFIRMED TO BE WITHIN SPECIFICATION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). THE ORACLE AND THE T-PAL SPACER SYSTEMS INCLUDE A SLAP HAMMER. THIS INSTRUMENT HELPS REMOVE TRIALS AND IMPLANTS. THE INSTRUMENT FAILED AT THE LOCATION OF THE PIN THROUGH THE THREADED CONNECTION. THIS PIN ACTS AS A STRESS RISER, LEADING TO THE FAILURE AT THIS LOCATION. IN ADDITION, THE MATERIAL MAY ALSO BE A FACTOR IN THE FAILURE DUE TO THE IMPACT LOADING OF THE DEVICE. THE DESIGN OF THE PIN THROUGH THE THREADED CONNECTION INCREASES THE LIKELIHOOD OF FAILURE AT THIS LOCATION. (B)(4)

    Description of Event or Problem · 1

    SALES CONSULTANT REPORTED AN ORACLE SLAP HAMMER THAT BROKE DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION SURGERY. THE SLAP HAMMER BROKE WHILE THE SURGEON WAS REMOVING THE TRIAL SPACER. THE DEVICE BROKE AT THE PROXIMAL END OF THE SHAFT. THERE WAS NO PATIENT ADVERSE EVENT. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ORACLE SLAP HAMMER THAT BROKE DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION SURGERY. THE SLAP HAMMER BROKE WHILE THE SURGEON WAS REMOVING THE TRIAL SPACER. THE DEVICE BROKE AT THE PROXIMAL END OF THE SHAFT. SURGERY WAS DELAYED FOR APPROXIMATELY 10 MINUTES; THERE WAS NO PATIENT ADVERSE EVENT. A REPLACEMENT IS REQUESTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SLOTTED MALLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580256 ORACLE SLAP HAMMER FZY SYNTHES MONUMENT 6552991

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR