BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP® PROXIMAL FEMUR HOOK PLATE 6 HOLES/205MM

    MDR report key: 5068736 · Received September 10, 2015

    Report

    Report Number
    2520274-2015-15792
    Event Type
    Injury
    Date Received
    September 10, 2015
    Report Date
    August 31, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    PK032032
    Adverse Event
    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 INITIALS ARE (B)(6). THERE IS NO REPORT OF A PRODUCT MALFUNCTION; HOWEVER, THIS DEVICE CANNOT BE DISASSOCIATED FROM THE REPORTED ADVERSE EVENT. IT IS UNKNOWN IF PLATE WAS EXPLANTED DURING REVISION SURGERY. THIS REPORT IS FOR ONE PROXIMAL FEMUR LOCKING COMPRESSION PLATE (LCP) HOOK PLATE. PART AND LOT NUMBER WERE NOT PROVIDED BY REPORTER. (B)(4). 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: 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 RETURNED 4.5MM LCP PROXIMAL FEMUR HOOK PLATE AND SIX UNKNOWN SCREWS WERE RECEIVED IN FAIRLY WORN CONDITION CONSISTENT IMPLANTATION AND REMOVAL. THE PLATE WAS MANUFACTURED IN MARCH 2015 AND IS OVER A YEAR OLD. THE ASSOCIATED DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. NO PRODUCT ISSUE WAS IDENTIFIED UPON EXAMINATION FOR THESE PARTS. DEVICE HISTORY RECORD REVIEW: MANUFACTURING DATE: MARCH 20, 2015. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO COMPLAINT RELATED ANOMALIES. THE DHR SHOWS THIS LOT OF 4.5MM PROXIMAL FEMUR PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. EXPLANT PROCEDURE OCCURRED ON AN UNKNOWN DATE. 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 PROXIMAL FEMUR LOCKING COMPRESSION PLATE (LCP) HOOK PLATE. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    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
    598064 4.5MM LCP® PROXIMAL FEMUR HOOK PLATE 6 HOLES/205MM PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 7950680

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention