BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5068733 · Received September 10, 2015

    Report

    Report Number
    2520274-2015-15791
    Event Type
    Injury
    Date Received
    September 10, 2015
    Report Date
    August 31, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE COMPLAINT CONDITION FOR AN UNKNOWN 7.3MM CANNULATED SCREW WITH UNKNOWN LOT NUMBER WAS LIKELY CAUSED BY PATIENT NON-COMPLIANCE OR A POSSIBLE NONUNION; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. NO PRODUCT ISSUE WAS IDENTIFIED UPON EXAMINATION OF THE RETURNED 4.5MM LCP PROXIMAL FEMUR HOOK PLATE (PART 242.122 / LOT 7950680) OR THE SIX (6) UNKNOWN INTACT SCREWS. A SMALL FRAGMENT OF A SCREW REMOVAL TOOL WAS FOUND LODGED IN THE PROXIMAL END OF THE 7.3MM CANNULATED SCREW. THAT FRAGMENT WILL BE ADDRESSED UNDER (B)(4). THE UNKNOWN 7.3MM CANNULATED SCREW AND THE LCP PROXIMAL FEMUR HOOK PLATE ARE IMPLANTS ROUTINELY USED IN THE 4.5MM LCP PROXIMAL FEMUR HOOK PLATES SYSTEM. THE DEVICE WAS RETURNED AND REPORTED TO HAVE BROKEN POSTOPERATIVELY. THIS CONDITION IS CONFIRMED; THE SHAFT HAS BROKEN OFF FROM THE HEAD OF THE SCREW ALONG A HOMOGENOUS FRACTURE SURFACE. IT IS LIKELY THAT A NONUNION ULTIMATELY LED TO FATIGUE FAILURE AND THIS COMPLAINT CONDITION. PATIENT NON-COMPLIANCE MAY HAVE ALSO CONTRIBUTED TO THIS CONDITION. THE BALANCE OF THE RETURNED DEVICE IS IN FAIRLY WORN CONDITION CONSISTENT WITH IMPLANTATION AND REMOVAL. THE ASSOCIATED DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT REVISION OF A PROXIMAL FEMUR LOCKING COMPRESSION PLATE (LCP) HOOK PLATE DUE TO THE CANNULATED LOCKING SCREW, LOCATED PROXIMALLY IN THE PLATE, HAVING SHEARED OFF AT THE HEAD OF THE SCREW. THE SURGERY WAS SUCCESSFULLY COMPLETED AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THE INITIAL IMPLANT WAS PERFORMED ON AN UNKNOWN DATE THREE MONTHS PRIOR TO THE DATE OF THIS REPORT. THERE WAS NO REPORT OF SURGICAL DELAY. THIS REPORT IS FOR ONE, UNKNOWN CANNULATED LOCKING SCREW. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE: DURING THE INVESTIGATION, WHICH BEGAN ON OCTOBER 8, 2015, A FRAGMENT OF A SCREW REMOVAL TOOL WAS DISCOVERED. THIS INFORMATION WILL BE CAPTURED IN AND REPORTED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600777 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention