BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/6 HOLES/LEFT

    MDR report key: 4736412 · Received April 29, 2015

    Report

    Report Number
    3003506883-2015-10078
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 10, 2015
    Report Date
    April 10, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    PK120854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 02.118.407, 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE, 6 HOLES, LOT NUMBER 7682607). THE SUBJECT DEVICE WAS RECEIVED WITH THE COMPLAINT THAT THE LOCKING SCREWS DID NOT LOCK INTO THE LOCKING PLATE. THE PRODUCT DEVELOPMENT INVESTIGATION INCLUDED THE REVIEW OF THE RELATED PRODUCT DRAWINGS AND TECHNIQUE GUIDES. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. ALTHOUGH THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED, THE MOST PROBABLE CAUSE IS THE METHOD OF USE OF FINAL TIGHTENING UNDER POWER OR NOT USING A TORQUE LIMITER. 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

    ADDITIONAL NARRATIVE: MANUFACTURING INVESTIGATION EVALUATION: PART 02.2118.407 / LOT 7682607 WAS RECEIVED ALONG WITH FIVE (5) SCREWS. FAINT SCRATCHES WERE FOUND IN THE VICINITY OF HOLES DVA1, DVA2, DVA3, AND DVA4. THE COSMETIC APPEARANCE OF THE PLATE WAS OTHERWISE CONSISTENT WITH THAT EXPECTED FROM NORMAL PRODUCTION. THE PART RECEIVED WAS VISUALLY INSPECTED UNDER MAGNIFICATION. EACH OF THE TEN (10) VARIABLE ANGLE HOLE FEATURES WERE INSPECTED. FIVE (5) WERE FOUND TO HAVE SUSTAINED DAMAGE NOT CONSISTENT WITH THE MANUFACTURING PROCESS. DUE TO THE EXTENT OF THE DAMAGE TO HOLES DVA1, DVA2, DVA3, DVA4, AND DVA6, DIMENSIONAL VERIFICATION RELATED TO THE COMPLAINT (IDENTIFIED AS FEATURE PDH, PITCH DIAMETER DEPTH OF DVA1 THRU DVA6) CANNOT BE PERFORMED. BASED ON THE COMPLAINT INFORMATION RECEIVED, IT IS DEDUCED THAT THE 5 HOLES FOUND TO BE DAMAGED ARE THOSE THAT THE PRODUCT USER ATTEMPTED TO UTILIZE. BASED ON THESE OBSERVATIONS, IT IS CONCLUDED THAT THE DEVICE EXHIBITS THE CONDITION DEFINED IN THE PRODUCT COMPLAINT. THEREFORE, THE COMPLAINT IS CONFIRMED; HOWEVER, NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/ OR CONFIRMED. AS SUCH, REVIEW OF THE SPECIFIC PRM AND PRM LINE ITEM IS NOT APPLICABLE. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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

    ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE: HWC. DEVICE WAS NOT IMPLANTED/EXPLANTED. THE MANUFACTURING PROCESS OF THIS PLATE WAS COMPLETED. NONE OF THE PLATES MANUFACTURED WITHIN THIS LOT WERE SCRAPPED AND THERE WERE NO NON-CONFORMANCES NOTED. RAW MATERIAL LOT 7511177 UTILIZED WAS ALSO ACCEPTED; NO SCRAP OF NON-CONFORMANCE WAS NOTED ON THE ROUTER. BASED ON THE ABOVE INFORMATION IT IS DETERMINED THAT ALL PROCESSES WERE FOLLOWED AS REQUIRED. ACCEPTED PRODUCT LOT MET THE ESTABLISHED ACCEPTANCE CRITERIA¿S AND NO MANUFACTURING ISSUES WERE FOUND THAT COULD HAVE LED TO 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

    FIVE UNKNOWN LOCKING SCREWS WERE IDENTIFIED AS: 2.7 MM VARIABLE ANGLE LOCKING SCREW SELF-TAPPING 18MM (QUANTITY ONE); 2.7 MM VARIABLE ANGLE LOCKING SCREW SELF-TAPPING 14MM (QUANTITY ONE); AND 2.7 MM VARIABLE ANGLE LOCKING SCREW SELF-TAPPING 12MM (QUANTITY THREE). THIS IS REPORT 1 OF 6 FOR (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOCKING SCREWS DID NOT LOCK INTO A LOCKING PLATE DURING A REPAIR OF A FRACTURED LEFT LATERAL MALLEOLUS FIBULA, WHICH TOOK PLACE ON (B)(6) 2015. A FEMALE PATIENT UNDERWENT REPAIR OF A FRACTURED LEFT LATERAL MALLEOLUS FIBULA WITH A 2.7MILLIMETER (MM)/3.5MM VARIABLE-ANGLE LOCKING COMPRESSION PLATE, LEFT LATERAL DISTAL FIBULA PLATE. DURING THE PROCEDURE, THE SURGEON NOTED THAT THE 2.7 LOCKING SCREWS (LENGTH UNKNOWN) DID NOT LOCK INTO THE PLATE. FIVE SCREWS WERE REMOVED ALONG WITH THE PLATE WITHOUT DIFFICULTY. NO FRAGMENTS WERE NOTED. THERE WAS A FIVE MINUTE SURGICAL DELAY. THE PATIENT WAS IMPLANTED WITH A SYNTHES NON-VARIABLE ANGLE LOCKING PLATE. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND PATIENT OUTCOME WAS FINE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283007 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/6 HOLES/LEFT PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 7682607

    Patients

    Seq Age Sex Outcome Treatment
    1