BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5150661 · Received October 14, 2015

    Report

    Report Number
    2520274-2015-16662
    Event Type
    Injury
    Date Received
    October 14, 2015
    Report Date
    September 30, 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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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

    PARTIAL PART NUMBER IDENTIFIED IN INVESTIGATION SUMMARY AS: 5.0MM VA CANNULATED LOCKING SCREW (PART # 02.231.6XX). THE BROKEN SCREW HEAD WAS NOT LEFT IN THE PATIENT, THE BROKEN HEAD IS NOT AVAILABLE FOR RETURN OR MANUFACTURER REVIEW/INVESTIGATION AND IT MOST LIKELY WAS DISCARDED. AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: ONE OF THE FOLLOWING DEVICE(S) WAS RECEIVED: 4.5MM VA-LCP CURVED CONDYLAR PLATE (PART # 02.124.412 / LOT # 8082858) 5.0MM VA CANNULATED LOCKING SCREW (PART # 02.231.6XX/ LOT # UNKNOWN), 11 ADDITIONAL INTACT SCREWS WERE RECEIVED WITH MINIMAL COSMETIC DAMAGE (SCRATCHES AROUND DRIVE RECESS FROM INSERTION AND REMOVAL) AND NO ALLEGED DEFICIENCY/COMPLAINT AGAINST THEM, A TOTAL OF ELEVEN (13) IMPLANTS WERE RECEIVED. THIS COMPLAINT IS CONFIRMED. THE RECEIVED PLATE IS BROKEN INTO TWO PIECES AT THE SECOND COMBI HOLE PROXIMAL TO THE CONDYLAR HEAD PORTION OF THE PLATE. THE HEAD OF ONE CANNULATED LOCKING SCREW WAS BROKEN OFF AND THE HEAD WAS NOT RETURNED. THE REMAINING ELEVEN (11) SCREWS HAD DAMAGE TO THE STARDRIVE AND HEXAGONAL DRIVE RECESSES THAT IS CONSISTENT WITH INSERTION AND REMOVAL. PER THE COMPLAINT DESCRIPTION A NON-UNION WAS PRESENT. ALTHOUGH THE EXACT CAUSE FOR THE COMPLAINT CONDITION CANNOT BE DETERMINED, IT IS LIKELY THAT EXCESSIVE, CYCLIC LOADING DUE TO THE NON-UNION CAUSED BOTH THE PLATE AND THE ONE SCREW TO FAIL. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. DEVICE WAS 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.

    Additional Manufacturer Narrative · 1

    PATIENT INITIALS: (B)(6). THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. EXACT DATE UNKNOWN, REPORTED AS APPROXIMATELY 18 MONTHS PRIOR TO EXPLANT ON (B)(6) 2015. (B)(6). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 24SEPTEMBER2012. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS 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

    UPDATE, 26 OCT 2015: (B)(6) CALLED BACK AND INDICATED THAT THE BROKEN SCREW HEAD WAS NOT LEFT IN THE PATIENT, THE BROKEN HEAD IS NOT AVAILABLE FOR RETURN AND IT MOST LIKELY WAS DISCARDED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION PROCEDURE WITH HARDWARE EXPLANT WAS PERFORMED ON (B)(6) 2015 AFTER IT WAS NOTED THE PATIENT HAD FIBROUS NON-UNION AND A BROKEN 4.5 VARIABLE ANGLE, CONDYLAR, LOCKING COMPRESSION PLATE (LCP). THE ORIGINAL IMPLANT PROCEDURE WAS PERFORMED APPROXIMATELY EIGHTEEN MONTHS AGO. DURING THE REVISION PROCEDURE THE BROKEN PLATE AND TWELVE SCREWS WERE REMOVED; IT WAS REPORTED ONE SCREW WAS BROKEN AND THE OTHER ELEVEN WERE INTACT. THE PATIENT WAS IMPLANTED WITH A NEW PLATE AND SCREWS. THE REVISION SURGERY WAS COMPLETED AND NO SURGICAL DELAY WAS REPORTED. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678831 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention