BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STER CORT SCREW - 4MM DIAM X 55MM LONG

    MDR report key: 2801438 · Received October 18, 2012

    Report

    Report Number
    9615741-2012-00085
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 28, 2012
    Report Date
    December 11, 2012
    Manufacturer
    NEWDEAL SAS
    Product Code
    HRS
    PMA / PMN Number
    K073375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LNTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 11/30/2012. THE INVESTIGATION INCLUDED. METHODS: EVALUATION OF COMPLAINT RELATED DEVICE; REVIEW OF DEVICE HISTORY RECORDS; REVIEW OF INTEGRA COMPLAINTS HISTORY FOR THE DEVICE. RESULTS: THE COMPLAINT RELATED TWO DEVICES WERE RECEIVED FOR EVALUATION, A VISUAL INSPECTION WAS PERFORMED THREE ANOMALIES WERE OBSERVED. ON THE SCREW BATCH NUMBER FOSN, THE HEXAGONAL PRINT WAS MATTING. NO MARK OR MACHINING DEFECT WAS OBSERVED. ON THE SCREW BATCH NUMBER EA1E, THE HEXAGONAL WAS MATTED AND THE SCREW HEAD IS DAMAGED DUE TO REMOVAL. A REVIEW OF THE DEVICE HISTORY RECORD OF LOT FOSN FOUND NO ANOMALIES DURING THE MANUFACTURING PERIOD OF THE PRODUCT. THE LOT FOSN WAS MANUFACTURED IN JULY 2011. A REVIEW OF THE DEVICE HISTORY RECORD OF LOT EA1E FOUND NO ANOMALIES DURING THE MANUFACTURING PERIOD OF THE PRODUCT. THE LOT WAS MANUFACTURED IN OCTOBER 2008. THERE WAS NO DESIGN CHANGE PERFORMED ON THIS PRODUCT ID SINCE 2007. A REVIEW OF THE COMPLAINT SYSTEM WAS PERFORMED. THIS IS THE FIRST INCIDENT (FOR THE PAST FIVE YEARS) REPORTED TO NEWDEAL ABOUT A STRIPPING HEXAGONAL SCREW HEAD. THE COMPLAINT RATE FOR THIS KIND OF INCIDENT DURING THE STATED TIME PERIOD IS (B)(4) PERCENT. CONCLUSION: BASED ON THE DESCRIPTION OF THE EVENT AND THE OBSERVATIONS MADE DURING THE INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT IS INAPPROPRIATE USE. THE USE OF THIS TYPE OF SCREW IS NOT ADAPTED TO THE COMPRESSION STAGE. INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES. PURSUANT TO 21 CFR 803 24 NEITHER THE FILING OF THIS MEDICAL DEVICE REPORT NOR THE INFORMATION CONTAINED HEREIN SHALL BE CONSTRUED AS AN ADMISSION OR ACKNOWLEDGEMENT THAT THE INFORMATION SUBMITTED TO INTEGRA LIFESCIENCES HOLDING CORPORATION OR ANY OF ITS SUBSIDIARIES IS VALID OR THAT THE DEVICE CAUSED OR CONTRIBUTED IN ANY WAY TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    IN ADDITION TO THE ALLEGED DEVICE INVOLVED IN THIS REPORT, ADDITIONAL PRODUCT NUMBER: 285328SND (STER. TI SCREW AND LOCK SCREW - 3.5MM X 28MM LGT) WAS USED DURING THIS PATIENT'S SURGERY. TO DATE THE DEVICES INVOLVED IN THE REPORTED INCIDENT HAVE NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. PURSUANT TO 21 CFR 803.24 NEITHER THE FILING OF THIS MEDICAL DEVICE REPORT NOR THE INFORMATION CONTAINED HEREIN SHALL BE CONSTRUED AS AN ADMISSION OR ACKNOWLEDGEMENT THAT THE INFORMATION SUBMITTED TO INTEGRA LIFESCIENCES HOLDING CORPORATION OR ANY OF ITS SUBSIDIARIES IS VALID OR THAT THE DEVICE CAUSED OR CONTRIBUTED IN ANY WAY TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    THE SURGEON REPORTED HE "HAD A RIGHT ANKLE ARTHRODESIS ON A MALE PATIENT. DUE TO (B)(6) HOSPITAL'S STERILIZATION RULES, THE STAINLESS STEEL 4MM COMPRESSION SCREWS HAD BEEN REMOVED FROM THE SET. TO ENABLE THE CASE TO GO AHEAD THE 4MM TITANIUM CORTICAL SCREWS WERE USED TO COMPRESS THE LATERAL PLATE IN PLACE OF THE MISSING COMPRESSION SCREWS. ONCE THE COMPRESSION HAD BEEN MADE, THE SURGEON PLACED THE FIRST OF THE 3.5MM TITANIUM SCREWS BUT THE HEAD OF THE SCREW STRIPPED WHEN THE SCREW WAS BEING SCREWED IN. THIS WAS THEN REMOVED WITH SOME DIFFICULTY. DURING THE CASE 2 OF THE 4MM CORTICAL SCREWS WHICH WERE BEING USED TO COMPRESS AGAINST ALSO STRIPPED WHEN BEING TAKEN OUT. SURGERY TIME WAS INCREASED BY 20 MINUTES; THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610727 STER CORT SCREW - 4MM DIAM X 55MM LONG N/A HRS NEWDEAL SAS 1XFOSN 1XFA1E

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male