BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK/SCREW HOLDER WITH 4.0MM HEX

    MDR report key: 3080335 · Received April 26, 2013

    Report

    Report Number
    2530088-2013-10544
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    January 31, 2012
    Report Date
    January 31, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. THE SLEEVE AND HOLDING PIN WERE RECEIVED FOR INVESTIGATION AND THE PRODUCT EVALUATION AND VISUAL INSPECTION OF THE RETURNED PARTS REVEALED THAT THE COMPLETE HEXAGON TIP AND A PART OF THE SLEEVE BODY HAS BROKEN OFF. THE BROKEN PARTS WERE ALSO RETURNED. IN ADDITION, THE INSIDE HOLDING PIN IS BADLY BENT. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE AND NO MANUFACTURING RELATED FAULT COULD BE DETECTED. CONCLUSION- THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A UNIVERSAL SPINE SYSTEM, USS SYSTEM, AT L4-S1 ON AN UNKNOWN DATE. PATIENT RETURNED TO OPERATING ROOM FOR REVISION SURGERY AND REMOVAL OF HARDWARE ON (B)(6) 2012. THE PATIENT DEVELOPED ADJACENT LEVEL DISEASE AT L2-L3, L3-L4 AND PATIENT HAD A SOLID FUSION FROM L4-S1. SURGEON REMOVED ALL THE HARDWARE, 6 SCREWS, 6 NUTS, 6 COLLETS, AND 2 RODS AND THE PATIENT WAS REVISED WITH A NEW USS DUAL-OPENING SYSTEM AT L2-S1. DURING THE REVISION SURGERY, THE HOOK/SCREW HOLDER BROKE DUE TO TOO MUCH TORQUE. SURGEON THEN USED ANOTHER SCREWDRIVER TO SEAT THE SCREW AND THIS SCREWDRIVER BROKE AT THE HANDLE. THE SCREWDRIVER JUST KEPT SPINNING. SURGEON THEN TRIED TO PLACE A SHORT ROD TO BACK OUT THE SCREW. SURGEON GOT THE COLLARS TO ENGAGE WITH SCREW, HOWEVER, THE NUT OF THE COLLARS, WOULD NOT ENGAGE WITH THE DUAL-OPENING SCREW AND THE SURGEON USED A ROD HOLDER TO BACK OUT THE SCREW. THE SURGEON WAS ABLE TO REPLACE AND SEAT THE SCREW. DURING THE ADJUSTMENT OF THE SCREW, THE OTHER HOOK/SCREW HOLDER BROKE. THE SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS AND NO HARM TO PATIENT. ALL BROKEN FRAGMENTS WERE RETRIEVED. THE REMOVED IMPLANTS ARE BEING RETURNED TO THE PATIENT AND ARE UNAVAILABLE FOR RETURN. THE PART NUMBERS AND LOT NUMBERS FOR THE REMOVED HARDWARE ARE UNOBTAINABLE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 23 OF 23 FOR (B)(4) AND IS THE REPORT FOR THE SECOND HOOK/SCREW HOLDER THAT BROKE. INDIVIDUAL REPORTS HAVE BEEN FILED FOR EACH OF THE 6 SCREWS, 6 NUTS, 6 COLLETS, 2 RODS, ONE REPORT FOR THE SCREWDRIVER THAT BROKE AT THE HANDLE AND ONE FOR THE OTHER HOOK SCREW HOLDER THAT BROKE.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 30 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183148 HOOK/SCREW HOLDER WITH 4.0MM HEX LXH SYNTHES BRANDYWINE 4558778

    Patients

    Seq Age Sex Outcome Treatment
    1