BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 26MM

    MDR report key: 9860987 · Received March 20, 2020

    Report

    Report Number
    3006460162-2020-00045
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Report Date
    May 28, 2020
    Manufacturer
    ORTHOPEDIATRICS, INC
    Product Code
    HWC
    UDI-DI
    00841132110881
    PMA / PMN Number
    K100240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4: DATE OF THIS REPORT: 5/28/2020. G7: TYPE OF REPORT: FOLLOW-UP. H3: DEVICE EVALUATED: YES. H2: FOLLOW-UP TYPE: ADDITIONAL INFORMATION, DEVICE EVALUATION. H4: DEVICE MANUFACTURE DATE: 20-APRIL-2017. H6: EVENT PROBLEM AND EVALUATION CODES: METHOD CODE(S): 3331 - 10 - 4110. RESULT CODE(S): 3252. CONCLUSION CODE(S): 22 - 4315. SCREW WAS EVALUATED AND THE REPORTED FRACTURE WAS CONFIRMED. A DHR REVIEW WAS CONDUCTED AND NO MANUFACTURING DESCREPANCIES WERE IDENTIFIED. A REVIEW OF THE APPLICABLE RISK MANAGMENT FILE WAS CONDUCTED AND IDENTIFIED BENDING AND OR FRACTURING POST-OPERATIVELY. THIS RISK FALLS WITHIN THE ACCEPTANCE CRITERIA. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ORTHOPEDIATRICS WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT DEVICES: ITEM: 00-0903-2522, 3.5MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 22MM, LOT: 178767-J; ITEM: 00-0907-3760, 3.5MM CANNULATED LOCKING SCREW, 60MM, LOT: M72783-D; ITEM: 00-0907-3760, 3.5MM CANNULATED LOCKING SCREW, 60MM, LOT: M72783-D; ITEM: 00-0907-3755, 3.5MM CANNULATED LOCKING SCREW, 55MM, LOT: M70765-D; ITEM: 00-0903-2528, 3.5MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 28MM, LOT: 171316-J; ITEM: 00-0903-2524, 3.5MM SELF TAPPING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 24MM, LOT: 178768-J; ITEM: 00-0907-2104, 130° X 3.5MM LPF PLATE X 4 HOLE, LOT: 046734-G. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF RETURNING TO ORTHOPEDIATRICS FOR EVALUATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 30064660162-2020-00046.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING THE PLANNED REMOVAL OF A LOCKING PROXIMAL FEMUR PLATE, TWO SCREWS FRACTURED. A DELAY GREATER THAN THIRTY MINUTES WAS NOTED. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324278 3.5MM LOCKING CORTICAL SCREW WITH T15 HEXALOBE, SIZE 26MM SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, INC N/A 171334-J 00841132110881

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR