BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM/3.5MM TI LCP POSTLAT DSTL FIBULA PL 4H/LEFT/90MM

    MDR report key: 6828600 · Received August 29, 2017

    Report

    Report Number
    1719045-2017-10857
    Event Type
    Malfunction
    Date Received
    August 29, 2017
    Date of Event
    August 8, 2017
    Report Date
    August 9, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    UDI-DI
    07611819388697
    PMA / PMN Number
    K083213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT WAS REPORTED. IT WAS NOT REPORTED THAT DEVICE WAS IMPLANTED/EXPLANTED COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. HOSPITAL CONTACT TELEPHONE: (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW WAS COMPLETED. DHR REVIEW FOR PART #04.112.109, SYNTHES LOT #6263373 RELEASE TO WAREHOUSE DATE: 09-MAR-2010, 29-NOV-2010, 26-MAY-2011 MANUFACTURED BY SYNTHES (B)(4). (B)(4) WAS GENERATED FOR 3 OF 12 PARTS THAT HAD A GAGE DISCREPANCY. DEBRIS WAS REMOVED FROM THE GAGE, RE-TESTED, AND ALL PASSED INSPECTION. RELEVANCE TO THE COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE ARE POTENTIAL ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    A PRODUCT INVESTIGATION WAS PERFORMED. THE RETURNED PLATE WAS CONFIRMED TO BE BROKEN ON THE DISTAL END, ACROSS THE MIDDLE TWO LOCKING HOLES (WHICH ACCEPT 2.4 AND 2.7 LOCKING SCREWS). THE DEVICE SHOWS SURFACE SCRATCHES WHICH INDICATE THAT THE DEVICE MAY HAVE BEEN IMPLANTED OR IMPLANTATION WAS ATTEMPTED. THE HEAVIEST SCRATCHES ARE LOCATED NEAR THE BREAKAGE, WHICH MAY INDICATE INTENTIONAL BENDING OF THE PLATE. DEVICE HISTORY RECORD (DHR) REVIEW FOR PART #04.112.109, SYNTHES LOT #6263373: NON-CONFORMANCE REPORT (NCR) WAS GENERATED FOR 3 OF 12 PARTS THAT HAD A GAGE DISCREPANCY. DEBRIS WAS REMOVED FROM THE GAGE, RE-TESTED, AND ALL PASSED INSPECTION. THE NCR IS NOT RELEVANT TO THE COMPLAINT CONDITION AS THE ISSUE WAS WITH THE GAGE, NOT THE PART. THE PARTS WERE RE-INSPECTED AND PASSED. THE MATERIAL WAS DETERMINED TO BE ACCEPTABLE BASED ON REVIEW OF THE DHR. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. NO ADDITIONAL MALFUNCTIONS WERE OBSERVED DURING INVESTIGATION. THE RELEVANT DRAWINGS WERE REVIEWED DURING INVESTIGATION. THE PLATE THICKNESS ON EITHER SIDE OF THE BREAK WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION PER RELEVANT DRAWING. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THE CONDITIONS EXPERIENCED BY THE PLATE AT THE TIME OF BREAKAGE ARE UNKNOWN. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DESIGN HISTORY WAS NOT FOUND TO IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PHYSICIAN REPORTED THE 2.7MM/3.5MM LOCKING COMPRESSION PLATE (LCP) POSTEROLATERAL DISTAL FIBULA PLATE IS BROKEN. NO FURTHER INFORMATION IS AVAILABLE, NO PATIENT INVOLVEMENT IS REPORTED. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM LOCKING COMPRESSION PLATE (LCP) POSTEROLATERAL DISTAL FIBULA PLATE THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607772 2.7MM/3.5MM TI LCP POSTLAT DSTL FIBULA PL 4H/LEFT/90MM PLATE,FIXATION,BONE HRS SYNTHES MONUMENT 6263373 07611819388697

    Patients

    Seq Age Sex Outcome Treatment
    1