BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5221587 · Received November 13, 2015

    Report

    Report Number
    2520274-2015-17229
    Event Type
    Injury
    Date Received
    November 13, 2015
    Report Date
    October 28, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE PART FAMILY (PART NUMBER 02.205.XXX) THE BRAND NAME WOULD BE: 5.0MM CANNULATED LOCKING SCREWS. THE COMPLAINANT PART INCLUDES A VARIETY OF UNKNOWN LENGTHS. BASED ON THE PART FAMILY, ONE OF THE FOLLOWING TWO 510(K) NUMBERS ARE LIKELY: K000066, K040765. THE RETURNED UNKNOWN CANNULATED LOCKING SCREW WAS RECEIVED STUCK IN THE SECOND MOST DISTAL LOCKING HOLE IN THE PLATE. THE SCREW WAS INTACT BUT SHOWING SIGNIFICANT DAMAGE TO THE DRIVE RECESS AND COULD NOT BE REMOVED FROM THE PLATE. THIS DAMAGE IS CONSISTED WITH USE OF THE EXTRACTION SCREW DURING REMOVAL. GIVING THE DAMAGE THE EXACT PART NUMBER COULD NOT BE DETERMINED. HOWEVER, BASED ON THE OBTAINABLE FEATURES AND RELATED PLATE, IT IS LIKELY FROM THE 5.0MM CANNULATED LOCKING SCREW FAMILY (PART NUMBER 02.205.XXX). NO ISSUES WERE REPORTED OR IDENTIFIED WITH THE RETURNED SCREW AS IT RELATES TO THE BROKEN PLATE. THE BREAK IS CONSISTENT WITH THE RESULT OF EXCESSIVE SHEAR FORCES AND ACCUMULATED WEAR AFTER THE PLATE FRACTURED. WHEN THERE IS INSUFFICIENT REDUCTION OR HEALING IS DELAYED THERE ARE INCREASED LOADS THE IMPLANT MUST WITHSTAND, THAT WOULD NORMALLY BE SUPPORTED BY THE BONE, WHICH COULD EVENTUALLY CAUSE IT TO BREAK DUE TO METAL FATIGUE. THIS IS FURTHER IMPACTED BY PATIENCE COMPLIANCE AND ACTIVITY LEVEL, COMORBIDITIES, AND THE SURGICAL TECHNIQUE. THE ORIGINAL IMPLANT DATE WAS REPORTED TO HAVE BEEN IN 2006 AND IT IS UNKNOWN WHEN OVER THE APPROXIMATELY 8.8 TO 9.8 YEARS BEFORE EXPLANT THAT THE FRACTURE OCCURRED. THUS, SINCE THE SPECIFIC CONDITIONS AT THE TIME OF THE BREAK ARE UNKNOWN, THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED. A REVIEW OF THE CURRENT DESIGN / DESIGN HISTORY FOR THE PROBABLE SCREW FAMILY (02_205_025) WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS ORIGINALLY IMPLANTED SOMETIME IN 2006. (B)(4). SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY PLATED IN 2006 FOR A DISTAL FEMUR FRACTURE. THE PLATE A 4.5MM LOCKING COMPRESSION PLATE LCP CONDYLAR PLATE 8 HOLES 206 MM RIGHT BROKE. WHILE THE SURGEON WAS USING THE CONICAL EXTRACTION SCREW TO GET THE UNKNOWN LOCKING SCREW OUT, THE TIP OF THE CONICAL EXTRACTION SCREW BROKE AND WAS STUCK INTO THE PLATE. THE PLATE WAS EXPLANTED ALONG WITH AN UNKNOWN LOCKING SCREW THAT WAS COLD-WELDED TO THE PLATE ON (B)(6) 2015. IT IS UNKNOWN HOW OR WHEN THE PLATE BROKE. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL TIME DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL TIME DELAY. THE PATIENT STATUS OUTCOME IS UNKNOWN. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751827 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention