BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/5 HOLES/RIGHT

    MDR report key: 4151260 · Received October 8, 2014

    Report

    Report Number
    3003506883-2014-10122
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    PK120854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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: AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: (B)(4), THE RETURNED PLATE WE HAVE SENT TO THE MANUFACTURER FOR INVESTIGATION; HERE IS THE RESULT. BY THE DVA 4 HOLE HAS RAISED BURR ON TOP OF HOLE AT OUTSIDE EDGE. INSPECTION UNDER MICROSCOPE SHOWS DAMAGED THREADS IN VA HOLE. THE PLATE WAS INSPECTED FOR DISTAL VA HOLE PITCH DIAMETER DEPTH AND MINOR DIAMETER. HOLES WERE FOUND CONFORMING EXCEPT FOR DVA4 WHICH WAS DAMAGED. WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS REPORTED PROBLEM, WE CAN ONLY ASSUME THAT THE INSERTING ANGLE FROM THE SCREWS CAUSED TO THIS DAMAGE, THEN IN TECHNIQUE GUIDE ((B)(4)) IS WRITTEN ¿LOCKING SCREWS Ø 2.7 MM MUST BE INSERTED AT ZERO DEGREES AND MUST BE TIGHTENED TO 1.2 NM.¿ THE DEVICE HISTORY RECORD SHOWS THIS LOT OF VA-LCP LATERAL DISTAL FIBULA PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING (JULY 2014) AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. NO PRODUCT FAULT COULD BE DETERMINED. 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: MANUFACTURING EVALUATION REPORTS THE DEVICE RETURNED FOR INSPECTION, DVA 4 HOLE HAS RAISED BURR ON TOP OF HOLE AT OUTSIDE EDGE. INSPECTION UNDER MICROSCOPE SHOWS DAMAGED THREADS IN VA HOLE. PART WAS INSPECTED FOR DVA HOLE PITCH DIAMETER DEPTH AND MINOR DIAMETER. HOLES WERE FOUND CONFORMING EXCEPT FOR DVA4 WHICH WAS DAMAGED. THE EXACT CAUSE OF THE REPORTED ISSUED IS UNDETERMINED. THE REPORTED ISSUE IS POSSIBLY INDICATIVE OF AN ANGLED INSERTION OF THE SCREWS DURING USAGE. PER THE TECHNIQUE GUIDE, LOCKING SCREWS 2.7MM MUST BE INSERTED AT ZERO DEGREES AND MUST BE TIGHTENED TO 1.2NM. NO PRODUCT FAULT COULD BE DETERMINED. THE SCREWS HAVE BEEN FORWARDED FOR ADDITIONAL EVALUATION. 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: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF VARIABLE ANGLE-LOCKING COMPRESSION PLATE LATERAL DISTAL FIBULA PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS AT TIME OF ACCEPTANCE. NO NONCONFORMING REPORTS WERE NOTED. THE RAW MATERIAL MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED. 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 (B)(4) REPORTS AN EVENT IN (B)(6).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SURGEON WAS COMPLETING A ROUTINE OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FIBULA USING THE VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) LATERAL DISTAL FIBULA PLATE. THE PLATE WAS TEMPORARILY AFFIXED TO THE PATIENT WITH 2 1.6MM KIRSCHNER WIRES. HE USED THE VA-LCP COAXIAL DRILL SLEEVE AND THE 2.0MM DRILL BIT TO DRILL HIS PILOT HOLE IN PREPARATION FOR PLACEMENT OF HIS FIRST 2.7MM STANDARD LOCKING SCREW IN THE DISTAL PORTION OF THE PLATE. HE CHOSE A 16MM STANDARD LOCKING SCREW AND INSERTED IT INTO THE PREDRILLED HOLE. DOCTOR USED THE 0.8 NM TORQUE LIMITING ATTACHMENT WHILST INSERTING THE SCREW. ON ADVANCING THE SCREW THE SCREW HEAD DID NOT ENGAGE IN THE PLATE. THE HOLE THAT WAS USED WAS A VA LOCKING HOLE (2ND HOLE IN FROM THE MOST DISTAL PORTION OF THE PLATE THAT IS ALMOST IN LINE WITH THE COAXIAL HOLE ON THE POSTERIOR ASPECT OF THE PLATE). THE SCREW HEAD WAS PARTIALLY IN THE PLATE AND CONTINUED TO TURN IN THE SAME POSITION, WITHOUT ADVANCEMENT ON FURTHER CONTINUED TURNS OF THE SCREWDRIVER. HE REPLACED THE 16MM 2.7 STANDARD LOCKING SCREW WITH A 14MM 2.7 STANDARD LOCKING SCREW AND THE SAME SCENARIO OCCURRED. HE THEN TOOK THE PLATE OFF THE PATIENT. HE PLACED THE SCREW INTO THE PLATE WITHOUT IT BEING ON THE PATIENT AND TRIED TO INSERT THE SCREW SO HE COULD GET A BETTER UNDERSTANDING OF WHAT WAS HAPPENING. THE SCREW AGAIN, CONTINUED TO TURN AND NOT ENGAGE IN THE PLATE. HE THEN PROCEEDED TO USE THE LCP LATERAL DISTAL FIBULA PLATE THE HOSPITAL HAS ON SHELF. HE NOTED THAT ON PLACEMENT OF EVERY 2.7 SCREW IN THE DISTAL PORTION OF THE LCP PLATE THERE WAS THE CORRECT CLICK OF THE TORQUE LIMITING ATTACHMENT. NO ADVERSE PATIENT RELATED ISSUES POST-SURGERY. THERE WAS A TWENTY MINUTE DELAY IN THE PROCEDURE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632619 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/5 HOLES/RIGHT PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 7732572

    Patients

    Seq Age Sex Outcome Treatment
    1