BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW

    MDR report key: 2854391 · Received December 3, 2012

    Report

    Report Number
    2520274-2012-03464
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    October 1, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. A MANUFACTURING EVALUATION WAS CONDUCTED. THE SCREWS WERE RECEIVED WITH NO PART NUMBERS NOR LOT NUMBERS PROVIDED. THIS SCREW IS BROKEN OFF JUST BELOW THE HEAD AT THE NECK AREA. IT IS THREADED HEAD, STARDRIVE, AND 3.5MM SHAFT THREAD DIAMETER SUGGESTS THAT THIS MAY BE OF THE 212.101 FAMILY OF SCREWS. IF SO, IT IS (CALCULATED) LENGTH OF 40.65MM WOULD MAKE THIS A 212.117. THE DRIVE IS LIGHTLY DAMAGED CONSISTENT WITH NORMAL USE. THE TOP OF THE HEAD IS IN GOOD CONDITION. THE FIRST HEAD THREAD NEAREST THE TOP OF THE HEAD HAS BEEN IMPACTED, DEFORMING THE THREAD DOWNWARDS AND AFFECTING PROFILE. THE LAST TWO THREADS ALSO HAVE IMPACT MARKS TO A LESSER DEGREE BUT THAT ALSO AFFECT THREAD PROFILE. THE SHAFT THREADS HAVE EXTRACTION TOOL MARKS AT THE TOP OF THE SHAFT (NEAREST THE HEAD) BUT ARE OTHERWISE IN GOOD CONDITION. THE FLUTES AND TIP AND IN GOOD CONDITION. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT ENGINEER EVALUATED THE DEVICE AND THE REPORT INDICATES THREE LOCKING SCREWS ARE BROKEN AT THE HEAD / SHAFT INTERFACE. NO DESIGN EVALUATION IS POSSIBLE BECAUSE THE PART NUMBERS, PROCEDURE AND THE PLATE USED WITH THE SCREWS ARE ALL UNKNOWN. INDICATIONS FOR USE AND THE DESIGN HISTORY FILE ARE BASED ON THE PLATE / PROCEDURE, AND SO CANNOT BE EVALUATED. 3.5 MM LOCKING SCREWS ARE DESIGNED WITH STANDARD SYNTHES IMPLANT GRADE 316L SS. WITHOUT ADDITIONAL INFORMATION, IT IS NOT POSSIBLE TO EVALUATE THE DESIGN, RISK ANALYSIS OR COMPLAINT HISTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING AN ORIF HIP SURGERY. AT SIX WEEKS FOLLOWING THE SURGERY, UPON X-RAY, THE SURGEON FOUND ONE SCREW BROKEN. THE FRACTURE APPEARED TO BE UNITED. THE SURGEON NOTED GOOD PLATE TO BONE OPPOSITION. ON (B)(6) 2012, THE SURGEON PERFORMED A REVISION DUE TO NON-UNION. TWO ADDITIONAL SCREWS WERE FOUND BROKEN. ALL HARDWARE WAS EXPLANTED AND THE SURGEON REVISED THE PATIENT WITH A PEDI-HIP SCREW, STABILIZING THE ORIGINAL OSTEOTOMY. THIS IS REPORT # 3 OF 4 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW LOCKING SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention