BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 30

    MDR report key: 6225353 · Received January 5, 2017

    Report

    Report Number
    3005180920-2016-00707
    Event Type
    Malfunction
    Date Received
    January 5, 2017
    Report Date
    February 8, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS DETECTED DURING A CHECK AFTER SURGERY ON (B)(6) 2016, BUT THE SURGERY DATE WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED ON 15 DECEMBER 2016 AND INCLUDES: THERE WILL BE NO SURGICAL INTERVENTION FOR THIS CASE. THE WRONG SCREWS WERE IMPLANTED DUE TO AN ERROR OF NURSING DURING THE SURGERY. THE ASSISTANT AND THE SURGEON DIDN'T CHECK THE REFERENCE AND NAME OF SCREWS. BATCH REVIEWS PERFORMED ON 29 DECEMBER 2016. LOT 154187: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 OCTOBER 2015. EXPIRATION DATE: 2020-10-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 40, CODE 01.26.65.40, LOT. 148377 (K103352). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 APRIL 2015. EXPIRATION DATE: 2020-02-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 05 JANUARY 2017 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION AND COMMENTED AS FOLLOWS: THE DIFFERENCE BETWEEN THE VERSAFITCUP SCREW AND THE MPACT ONE IS THE HEAD OF THE SCREW. THE HEAD OF THE VERSAFITCUP SCREW HAS BOTH THE MAXIMUM DIAMETER AND THE HEIGHT SLIGHTLY LARGER THAN THE MPACT ONE. THAT COULD POTENTIALLY CAUSE, DEPENDING ON BOTH THE TOLERANCES RELATIVE TO THE PARTS IMPLANTED AND THE INVOLVED SIZES OF SHELL AND LINER, CONTACT BETWEEN THE HEAD OF THE SCREW AND THE LINER, SPECIALLY IF THE SCREW IS INCLINED AS MUCH AS POSSIBLE IN RESPECT OF THE HOLE OF THE SHELL. WE ASKED FOR MORE INFORMATION ON THE MATERIAL AND SIZE OF LINER USED. THE REAL RISKS OF THE EVENT CANNOT BE DETERMINED WITH THE INFORMATION KNOWN TO DATE. DEVICE NOT EXPLANTED.

    Description of Event or Problem · 1

    DURING A CHECK AFTER SURGERY, IT WAS NOTICED THAT 2 VERSAFITCUP SYSTEM SCREWS WERE USED WITH A MPACT CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9198 VERSAFITCUP CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 30 CANCELLOUS BONE SCREW LZO MEDACTA INTERNATIONAL SA 154187

    Patients

    Seq Age Sex Outcome Treatment
    1 Other