BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM

    MDR report key: 7218766 · Received January 25, 2018

    Report

    Report Number
    0009610622-2018-00032
    Event Type
    Injury
    Date Received
    January 25, 2018
    Date of Event
    March 16, 2016
    Report Date
    March 7, 2018
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED THE BROKEN NAIL AND THE BROKEN LOCKING SCREW TO BE PRIMARY PRODUCTS WHEREOF THE BROKEN NAIL WAS REGARDED AS MAIN PRODUCT. FOR BOTH UNITS NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). BOTH IMPLANTS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. NO DEFICIENCY FOUND DURING DIMENSIONAL INSPECTION OF THE RETURNED PRODUCT. AVAILABLE INFORMATION REVEALED THAT THE NAIL ALLEGEDLY BROKE AFTER A PERIOD OF APPROX. 2 MONTHS OF IMPLANTATION. THE APPEARANCE OF THE BREAKAGES SURFACES INDICATED THE NAIL HAD BROKEN IN FATIGUE MANNER CONTRIBUTED BY SIGNIFICANT TENSILE AND TORSION STRESSES. IN THIS CASE, ACCORDING TO X-RAYS DATED MARCH 10, 2016, THE LOCKING SCREW HAD BROKEN PRIOR TO THE NAIL. NAIL BREAKAGE WAS CLEARLY DOCUMENTED ON MARCH 16, 2016. MEDICAL REVIEW REVEALED THE IMPLANTS HAD BEEN PLACED IN A COMPLEX OBLIQUE FOUR PART FRACTURE. FULL WEIGHT BEARING ON THE LEFT LEG HAD BEEN ALLOWED. FROM TECHNICAL POINT OF VIEW THE RETURNED NAIL BROKE IN FATIGUE MANNER CONTRIBUTED BY HIGH LOAD APPLICATION CONFIRMED BY SIGNIFICANT DISPLACED MATERIAL IN THE MEDIAL BEARING POINTS. IT COULD NOT BE DETERMINED IF THE MISSING PROXIMAL PART OF THE NAIL HAD BEEN DAMAGED INTRA OPERATIVELY. FROM TECHNICAL POINT OF VIEW THE NOT RETURNED SCREW MOST LIKELY BROKE DUE TO EXCEEDING AXIAL LOAD APPLICATION. AS NO DEVIATION WAS FOUND IN THE MANUFACTURING DOCUMENTS A DEFICIENCY OF THE DOCUMENTED NAIL AND SCREW WAS NOT VERIFIED. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY CONSPICUITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE WERE NO ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT. NO NONCONFORMITY WAS IDENTIFIED. POTENTIAL ADVERSE EVENTS AND POTENTIAL ROOT CAUSES ARE / WERE STATED IN THE LABELING. THE EVENT WAS NOT LINKED TO A DEFICIENCY OF THE DEVICES BUT WAS RATHER LINKED TO PATIENT FACTORS. IN CASE FURTHER INFORMATION IS RECEIVED THE INVESTIGATION REOPENED.

    Description of Event or Problem · 1

    LAWYER OF PATIENT REPORTS THAT ON (B)(6) 2016 PATIENT HAD SURGERY DUE TO FEMURAL NECK FRACTURE. THE REPORTED NAIL WAS IMPLANTED. THEREAFTER, THE PATIENT DID NOT HURT HIMSELF, DID NOT FALL, ETC, YET FELT PAIN AND RETURNED TO THE HOSPITAL. ON (B)(6) 2016 IT WAS DISCOVERED THAT THE NAIL WAS BROKEN. ADDITIONAL INFORMATION RECEIVED ON 01/25/18 INDICATED THAT LOCKING SCREW WITH LOT CODE K217187 WAS ALSO BROKEN.

    Description of Event or Problem · 1

    LAWYER OF PATIENT REPORTS THAT ON (B)(6) 2016 PATIENT HAD SURGERY DUE TO FEMORAL NECK FRACTURE. THE REPORTED NAIL WAS IMPLANTED. THEREAFTER, THE PATIENT DID NOT HURT HIMSELF, DID NOT FALL, ETC, YET FELT PAIN AND RETURNED TO THE HOSPITAL. ON (B)(6) 2016 IT WAS DISCOVERED THAT THE NAIL WAS BROKEN. ADDITIONAL INFORMATION RECEIVED ON 01/25/18 INDICATED THAT LOCKING SCREW WITH LOT CODE K217187 WAS ALSO BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62467 LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K217187

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention