BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10° ANGLE FOR PIP ARTHRO

    MDR report key: 3924643 · Received July 10, 2014

    Report

    Report Number
    0008031020-2014-00301
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HTY
    PMA / PMN Number
    K112197
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 REPORTED EVENT THAT SMART TOE IMPLANT HAD A BREAKAGE AFTER SURGERY COULD BE CONFIRMED SINCE THE DEVICE WAS RETURNED FOR EVALUATION. THE BREAKAGE OCCURRED WITHIN 6 WEEKS. BASED ON COMPLAINT HISTORY AND PREVIOUS CASES, IT HAS BEEN IDENTIFIED THAT SMART TOE IMPLANTS CAN BREAK WHEN PATIENT IS OBESE OR WHEN PATIENT DOES NOT RESPECT POSTOPERATIVE CARE OR WHEN PATIENT KEEPS AN IMPORTANT ACTIVITY WITHIN 6 WEEKS AFTER SURGERY. ALL OF THESE REASONS COULD NOT BE EXCLUDED IN THIS CASE: NO INFORMATION HAS BEEN PROVIDED REGARDING PATIENT WEIGHT, HEIGHT, POST-OPERATIVE CARE AND THE PATIENT IS (B)(6), WHICH MEANS THAT HIS BONE QUALITY COULD NOT BE OPTIMAL (OSTEOPOROSIS). IN ADDITION, A PREVIOUS STATEMENT WAS PROVIDED BY OUR CLINICAL EXPERT ON A SIMILAR CASE, HIS EXPERTISE READS: "THE SMART TOE IS INTENDED TO TRANSFER ONLY REDUCED LOADS (E.G. WITH PROTECTIVE APPLICATION OF A FOREFOOT OFF-LOADING SHOE) UNTIL BONE CONSOLIDATION IS CONFIRMED BY THE FOLLOW UP X-RAY EXAMINATION (NORMALLY AFTER 4 - 6 WEEKS). EARLY BREAKAGE OF A SMART TOE AFTER SUCH A SHORT PERIOD IS ONLY POSSIBLE WITH IMMEDIATE POSTOPERATIVE FULL WEIGHT BEARING AND/OR MASSIVE ACUTE OVERLOADING CAUSED BY AN ACUTE IMPACT INJURY (E.G. CAUSED BY AN UNINTENDED HIT). NO INFORMATION CONCERNING THE CIRCUMSTANCES OF THE IMPLANT BREAKAGE HAS BEEN SUBMITTED. THEREFORE, IT IS ONLY POSSIBLE TO GIVE A SHORT STATEMENT IN GENERAL." BASED ON THE INVESTIGATION RESULTS, THIS CASE IS CLASSIFIED AS PATIENT-RELATED (OVERLOADING). PLEASE NOTE THAT THE CURRENT OP TECH READS: "POSTOPERATIVE CARE: SMART TOE IMPLANTS ARE NOT INTENDED FOR IMMEDIATE POSTOPERATIVE WEIGHT BEARING. BE SURE THAT THE POSTOPERATIVE LOADING OF THE INTERNAL FIXATION IS REDUCED TO A MINIMUM (E.G. WITH APPLICATION OF A FOREFOOT OFF-LOADING SHOE) UNTIL BONE CONSOLIDATION IS CONFIRMED BY FOLLOW UP X-RAY EXAMINATION (NORMALLY AFTER 4-6 WEEKS)." [ORIGINAL STATEMENT - PAGE 14] PLEASE NOTE THAT THE CURRENT IFU READS: "RECOMMENDATIONS THE SIZE OF THE IMPLANT MUST BE ADAPTED TO THE PATIENT ANATOMY." [ORIGINAL STATEMENT] "PRECAUTIONS FOR USE - THE PRODUCT DOES NOT ALLOW THE IMMEDIATE RESUMPTION OF ACTIVITY BY THE PATIENT AND IS NOT DESIGNED TO SUPPORT AN IMMEDIATE LOAD. IMMOBILIZATION IS NECESSARY DURING THE OSTEOSYNTHESIS. - IT IS NECESSARY TO INFORM THE PATIENT OF THE PRECAUTIONS TO BE TAKEN TO ENSURE THE SUCCESS OF THE IMPLANTATION." [ORIGINAL STATEMENTS] "FACTORS CAPABLE OF COMPROMISING IMPLANTATION SUCCESS. - BONE PATHOLOGY, OSTEOPOROSIS, BONE TUMORS, SYSTEMIC OR METABOLIC PROBLEMS AND INFECTIOUS DISEASES. - EXCESS WEIGHT, INTENSE PROFESSIONAL OR SPORTING PHYSICAL ACTIVITY THAT EXPOSES THE IMPLANT TO EXCESSIVE OR REPEATED LOADS." [ORIGINAL STATEMENTS] A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OPERATIVELY SMART TOE IMPLANT WAS FRACTURED, SO THE DOCTOR EXPLANTED THEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OPERATIVELY SMART TOE IMPLANT WAS FRACTURED SO THE THE DOCTOR EXPLANTED THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404662 INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10° ANGLE FOR PIP ARTHRO PIN, FIXATION, SMOOTH HTY STRYKER TRAUMA SELZACH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention