BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6225389 · Received January 5, 2017

    Report

    Report Number
    3005180920-2016-00714
    Event Type
    Malfunction
    Date Received
    January 5, 2017
    Date of Event
    December 8, 2016
    Report Date
    January 5, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 29 DECEMBER 2016. LOT 161607: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 MAY 2016. EXPIRATION DATE: 2021-05-18. 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 35, CODE 01.26.65.35, LOT. 135325 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 JANUARY 2014. EXPIRATION DATE: 2018-12-31. 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 03 JANUARY 2017 THE (B)(4) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: ACCORDING TO REPORT, TWO SCREW HEADS WERE SHEARED OFF DURING PRIMARY THA IN A (B)(6) WOMAN. THE SCREW HEADS WERE RETRIEVED CORRECTLY AND THE SCREW SHAFTS REMAINED IN THE BODY. FROM THE CLINICAL POINT OF VIEW, THE SCREW SHAFTS WILL BE HARMLESS BECAUSE THEY WERE DESIGNED AND APPROVED FOR LONG TERM IMPLANTATION; THERE IS NO REASON TO BELIEVE THAT IN AN ELDERLY WOMAN THEY MAY MOVE AND BACK OUT DAMAGING THE PE INSERT. THE CAUSES FOR THE BREAKAGES MAY LIE IN A MECHANICAL PROBLEM OR IN A DIFFICULTY ARISEN DURING SURGERY, BUT IN NEITHER CASE THEY SHOULD BE OBJECT OF THE CLINICAL INVESTIGATION. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 05 JANUARY 2017 AND INCLUDES: THE SURGEON USED A DRILL GUIDE FOR THE PRE-HOLE AS SUGGESTED IN THE SURGICAL TECHNIQUE. ON 05 JANUARY 2017 THE (B)(4) PERFORMED A VISUAL INSPECTION OF THE RETRIEVED SCREW HEADS AND COMMENTED AS FOLLOWS: ON BOTH THE HEAD OF THE SCREWS ANALYSED SOME SIGNS CAN BE NOTED; SUCH SIGNS WERE LIKELY CAUSED BY THE REPEATED FRICTION BETWEEN THE HEAD OF THE SCREW AND THE SHELL DURING THE INSERTION OF THE SCREW. MOREOVER, THE BORDER OF ONE OF THE HEAD IS CLEARLY DAMAGED. THE FRICTION CAN BE CAUSED PROBABLY BY THE EXCESSIVE INCLINATION OF THE SCREW DURING THE INSERTION; THE X-RAY AVAILABLE SHOWS THAT BOTH THE SCREWS WERE DECISIVELY INCLINED. ONE OF THE POSSIBLE REASON COULD BE THE WRONG COUPLING BETWEEN THE DRILL GUIDE AND SHELL, DURING THE DRILLING OF THE PRE-HOLES. IT IS NOT POSSIBLE WITH SUCH INFORMATIONS TO DETERMINE ANY SURE CONCLUSION ON THE ROOT CAUSE OF THE PROBLEM.

    Description of Event or Problem · 1

    TWO BROKEN SCREW HEADS WERE FOUND IN 2 DIFFERENT SCREW HOLES. THE BODY OF THE SCREWS REMAINED INSIDE THE PATIENT BONE. THE TWO SCREW HEADS WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10220 VERSAFITCUP CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30 CANCELLOUS BONE SCREW LZO MEDACTA INTERNATIONAL SA 161607

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other