BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW FOR COMPRESSION FORECEPS DIA.4XL40

    MDR report key: 6694268 · Received July 7, 2017

    Report

    Report Number
    9615741-2017-00032
    Event Type
    Malfunction
    Date Received
    July 7, 2017
    Report Date
    June 21, 2017
    Manufacturer
    NEWDEAL SAS
    Product Code
    HWC
    PMA / PMN Number
    K953406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM INTEGRA INVESTIGATOR RECEIVED ON JULY 6, 2017: THIS SCREW P/N 159740 IS INSERTED THROUGH THE HOLE OF THE COMPRESSION FORCEPS AND IS USED TO APPLY COMPRESSION. AFTER THIS STEP, THE SCREW HAD TO BE REMOVED FROM PATIENT TO BE ABLE TO REMOVE FORCEPS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON JULY 18, 2017: LOCATION OF THE IMPLANTED UNIT: ANKLE, IMPLANTED TO THE SAME POSITION OF CORTICAL SCREW DIAM. 4.0 MM + DIAM. 6.0MM HEAD. THERE IS NO X-RAY AVAILABLE SHOWING THE SCREW IMPLANTED. THE SURGEON FOLLOWED STEP BY STEP THE SURGICAL TECHNIQUE. THE PATIENT IS NOT EXPERIENCING ANY SYMPTOMS. ADDITIONAL INFORMATION RECEIVED ON JULY 20, 2017: COMMENTS FROM DISTRIBUTOR : "I TALKED WITH THE DISTRIBUTOR WHO PERFORMED THE CASE, AS THEIR COMMENT THERE IS NOT ANY SYMPTOMS SUBMITTED BY PATIENT SO REVISION OPERATION IS NOT NEEDED AT THIS POINT. DURING OPERATION TECHNICAL SUPPORT FROM DISTRIBUTOR MISDIRECT THE OPERATOR TO USE COMPRESSION SCREW INSTEAD IMPLANTABLE ONE." INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON JULY 28, 2017. RESULTS: NO RETURN, THE INSTRUMENT IS IMPLANTED IN THE PATIENT. THE INCIDENT IS EVALUATED AS VALID BECAUSE THE COMPRESSION SCREW IS NOT INTENDED TO BE IMPLANTED IN THE PATIENT. DHR REVIEW; THE INTENDED USE OF THE SCREW FOR THE COMPRESSION IS WELL DEFINED IN THE SURGICAL TECHNIQUE AND PRODUCT IS CORRECTLY IDENTIFIED AS AN INSTRUMENT IN THE SURGICAL TECHNIQUE AND PRODUCT CODE IS LASER MARKED ON THE PRODUCT. IN COMPARISON WITH CORTICAL SCREW DIAM. 4.0MM, DIMENSIONS ARE SIMILAR TO COMPRESSION SCREW. THE ONLY DIFFERENCE IS THE RAW MATERIAL: CORTICAL SCREWS ARE MADE OF TITANIUM ALLOY (TI-6AL-4V) ACCORDING TO ISO 5832-3 AND F136 ASTM AND COMPRESSION SCREWS ARE MADE OF 316LVM STAINLESS STEEL ACCORDING TO ISO STANDARD 5832 1. BOTH ARE IMPLANTABLE MATERIAL USED FOR MEDICAL DEVICES. MECHANICAL PROPERTIES OF THOSE TWO MATERIALS ARE VERY SIMILAR (ESPECIALLY FOR MINIMAL TENSILE STRENGTH, YIELD STRENGTH AND ELONGATION). COMPLAINTS HISTORY; A REVIEW OF THE COMPLAINT SYSTEM WAS PERFORMED FOR LAST TWO YEARS. THIS IS THE SECOND INCIDENT FOR SIMILAR ISSUE LIKE DESCRIBED IN THIS COMPLAINT. AS COMPRESSION SCREWS ARE USED FOR EACH TIBIAXYS PLATES IMPLANTATION, THE NUMBER OF SOLD TIBIAXYS PLATES IS TAKEN INTO ACCOUNT. (B)(4) TIBIAXYS PLATES WERE SOLD DURING THE LAST 2 YEARS. THE RATE FAILURE IS RATED AT (B)(4). THE LOT FAILURE CANNOT BE EVALUATED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: THE FUNCTION OF THE COMPRESSION SCREW IS DEFINED IN THE SURGICAL TECHNIQUE USED BY THE SURGEON. PRODUCT IS LASER MARKED WITH ITS PART NUMBER AND THIS PART NUMBER IS INDICTED AS AN INSTRUMENT IN THE SURGICAL TECHNIQUE. A SURGICAL TECHNIQUE IS DELIVERED WITH THE TIBIAXYS SYSTEM. THE INCIDENT CAN BE EXPLAINED BY AN ERROR DURING THE SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SURGERY, THE DISTRIBUTOR RECEIVED INSTRUMENT TRAY AND IT WAS NOTICED SCREW WAS MISSING IN THE TRAY. AFTER THAT THE DISTRIBUTOR WAS INFORMED THE SCREW WAS IMPLANTED AND LEFT INTO PATIENT. NO PATIENT INJURY AND NO SURGICAL DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472801 SCREW FOR COMPRESSION FORECEPS DIA.4XL40 N/A HWC NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1