BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM

    MDR report key: 3931093 · Received July 14, 2014

    Report

    Report Number
    0009610622-2014-00321
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    July 1, 2013
    Report Date
    March 20, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED VIA X-RAYS. ALL BROKEN LOCKING SCREWS WERE CLASSIFIED AS PRIMARY PRODUCTS DURING INVESTIGATION. TECHNICAL EVALUATION: A REVIEW OF THE DHR WAS NOT POSSIBLE BECAUSE THE LOT CODE WAS NOT PROVIDED. AN INVESTIGATION OF ALL BROKEN SCREWS WAS NOT POSSIBLE BECAUSE THEY WERE NOT PROVIDED. CLINICAL EVALUATION: ALL AVAILABLE INFORMATION WAS EVALUATED BY A MEDICAL EXPERT. EXCERPT OF THE ASSESSMENT: "FINAL CONCLUSION: BASED ON THE PRESENTED DATA, THE BREAKAGES OF THE DISTAL LOCKING SCREWS WERE CAUSED BY EARLY OVERLOADING IN A COMPLETELY UNSTABLE FRAGMENT CONSTELLATION WITH INSUFFICIENT FRAGMENT REDUCTION.¿ NON-UNIONS AND POST-OPERATIVELY LOADS ARE LISTED AS ADVERSE EFFECTS IN THE IFU. FURTHERMORE THE OPERATIVE TECHNIQUE INCLUDES THE CORRECT HANDLING AND COMBINATION OF THE IMPLANTS. IF OTHER LISTED ADVERSE EFFECTS, LIKE INTRA-OPERATIVELY IMPLANT DAMAGES, OBESITY OR DIABETES, DID ALSO CONTRIBUTE TO THE SCREW BREAKAGES IS UNKNOWN DUE TO MISSING INFORMATION. NO NON-CONFORMITY IDENTIFIED; NO PREVIOUS OR ACTUAL ACTIONS ARE IN PLACE. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED VIA X-RAYS. A REVIEW OF THE DHR WAS NOT POSSIBLE FOR THE SCREW WITH CATALOG NUMBER 18965055S BECAUSE THE LOT CODE WAS NOT PROVIDED. ALL AVAILABLE INFORMATION WAS EVALUATED BY A MEDICAL EXPERT. EXCERPT OF THE ASSESSMENT: IN THE GIVEN CASE, THE X-RAYS SHOW POOR REDUCTION OF THE FEMORAL MAIN FRAGMENTS WITH INSUFFICIENT BONE-TO-BONE CONTACT. SUCH A CONSTELLATION IS ADVERSE BECAUSE ALL FORCES AND BENDING MOMENTS HAVE TO BE TRANSMITTED BY THE GAMMA-NAIL ALONE WITHOUT ANY SUFFICIENT SUPPORT BY THE BONE STRUCTURE. UNDER SUCH CIRCUMSTANCES, THE GAMMA NAIL IS NOT INTENDED FOR LONG TERM FULL WEIGHT BEARING. THIS IS EXPLICITLY NOTED IN THE INSTRUCTIONS FOR USE AND IN THE OPERATIVE TECHNIQUE AS WELL. NOTWITHSTANDING, THE SURGICAL REPORT DESCRIBES NO REAL LIMITATION OF POSTOPERATIVE WEIGHT BEARING: CURRENTLY, NO INFORMATION HAS BEEN PROVIDED WHETHER THE PATIENT HAS REDUCED OR LIMITED POSTOPERATIVE WEIGHT BEARING. BUT, THE TWO BROKEN DISTAL LOCKING SCREWS AFTER A VERY SHORT PERIOD OF APPROX. 3 WEEKS CLEARLY INDICATE TOO HIGH AND INAPPROPRIATE EARLY POSTOPERATIVE WEIGHT BEARING. BASED ON THE PRESENTED DATA, THE BREAKAGES OF THE DISTAL LOCKING SCREWS WERE CAUSED BY EARLY OVERLOADING IN A COMPLETELY UNSTABLE FRAGMENT CONSTELLATION WITH INSUFFICIENT FRAGMENT REDUCTION.¿ NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NONCONFORMITY IDENTIFIED; NO PREVIOUS OR ACTUAL ACTIONS ARE IN PLACE. PRODUCT DETAILS DISTAL LOCKING SCREW

    Description of Event or Problem · 1

    SALES REP REPORTS THAT A FEW WEEKS AFTER SURGERY, 2 SCREWS HAVE BROKEN.

    Description of Event or Problem · 1

    SALES REP REPORTS THAT A FEW WEEKS AFTER SURGERY, 2 SCREWS HAVE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411016 LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM IMPLANT HSB STRYKER TRAUMA KIEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention