BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    MDR report key: 4142505 · Received October 6, 2014

    Report

    Report Number
    0009610622-2014-00544
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 13, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE BROKEN NAIL AND BROKEN LOCKING SCREW WERE CLASSIFIED AS PRIMARY PRODUCTS DURING INVESTIGATION. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE IMPLANTS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE X-RAYS PROVIDED DID NOT SHOW WHERE THE BROKEN LOCKING SCREW WAS PLACED IN THE NAIL AND BONE; MOST LIKELY IT WAS PLACED IN ONE OF THE DISTAL NAIL HOLES. THE BREAKAGE SURFACE SHOWS LINES OF REST; AN INDICATION THAT THE SCREW BROKE ALSO IN A FATIGUE FRACTURE. IF THE SCREW BROKE PRIOR OR POST TO THE NAIL COULD NOT BE DETERMINED. THE CUSTOMER REPORTED THAT THE PATIENT LOADED THE IMPLANTS WITH FULL WEIGHT BEARING. POSTOPERATIVELY LOADS, STRENUOUS ACTIVITY OR ADDITIONAL TRAUMA CAN LEAD TO IMPLANT BREAKAGES AND ARE LISTED AS ADVERSE EFFECTS IN THE IFU; MOST LIKELY FULL WEIGHT BEARING DID CONTRIBUTE TO THE IMPLANT BREAKAGES. FURTHERMORE THE IFU INCLUDES THE WARNING THAT INTRA-OPERATIVELY IMPLANT DAMAGES SHALL BE AVOIDED. IF OTHER LISTED ADVERSE EFFECTS LIKE I.E. OBESITY OR DELAYED HEALING DID ALSO CONTRIBUTE TO THE IMPLANT BREAKAGES COULD NOT BE DETERMINED DUE TO MISSING INFORMATION. BECAUSE NO MANUFACTURER RELATED ISSUES WERE FOUND THE CASE IS ATTRIBUTED TO AN INTRA-OPERATIVELY IMPLANT DAMAGE CONTRIBUTED BY THE PATIENT. NO NON-CONFORMITY IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT A T2 RECONSTRUCTION NAIL (9 X 400) IMPLANTED INTO THE HIP OF A (B)(6) MALE PATIENT IN (B)(6) 2014 DURING PRIMARY SURGERY, HAS ALLEGEDLY BROKEN WHERE THE LAG SCREWS GO THROUGH THE NAIL, NEAR THE TOP. THE CUSTOMER FURTHER REPORTED THAT THE PATIENT ALLEGEDLY PRESENTED WITH PAIN IN THE HIP ON (B)(6) 2014 (APPROXIMATE DATE) AND WAS SENT FOR X-RAY EXAMINATION, WHICH INDICATED A REFRACTURE AT THE SAME SITE AND A BROKEN NAIL. REVISION SURGERY WAS DONE ON (B)(6) 2014 USING A SYNTHES (COMPETITOR) NAIL.

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT A T2 RECONSTRUCTION NAIL (9 X 400) IMPLANTED INTO THE HIP OF A (B)(6) MALE PATIENT IN (B)(6) 2014 DURING PRIMARY SURGERY, HAS ALLEGEDLY BROKEN WHERE THE LAG SCREWS GO THROUGH THE NAIL, NEAR THE TOP. THE CUSTOMER FURTHER REPORTED THAT THE PATIENT ALLEGEDLY PRESENTED WITH PAIN IN THE HIP ON (B)(6) 2014 (APPROXIMATE DATE) AND WAS SENT FOR X-RAY EXAMINATION, WHICH INDICATED A REFRACTURE AT THE SAME SITE AND A BROKEN NAIL. REVISION SURGERY WAS DONE ON (B)(6) 2014 USING A SYNTHES (COMPETITOR) NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624690 LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K03FB79

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention