BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/10 H/RT-STER

    MDR report key: 6648589 · Received June 16, 2017

    Report

    Report Number
    3003506883-2017-10115
    Event Type
    Injury
    Date Received
    June 16, 2017
    Report Date
    May 31, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K121601
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDED CONCOMITANT DEVICES. A PRODUCT INVESTIGATION WAS PERFORMED. ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) ANTEROLATERAL DISTAL TIBIA PLATE 2.7/3.5 (PART 02.118.208S / LOT 9951483) WAS RECEIVED WITH THE COMPLAINT CATEGORY OF BROKEN POSTOPERATIVELY. THE COMPLAINT CONDITION IS CONFIRMED. THE PLATE WAS RECEIVED WITH A ROUGHLY TRANSVERSE BREAK THROUGH THE LOCKING SIDE OF THE FIRST COMBI-HOLE FROM THE DISTAL PORTION OF THE PLATE. BOTH THE PROXIMAL AND DISTAL PORTIONS OF THE PLATE WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW, DEVICE INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. ONE (1) CORTEX SCREW, THREE (3) 3.5MM VA LOCKING SCREWS AND SIX (6) 2.7MM VA LOCKING SCREWS WERE RETURNED AS CONCOMITANT DEVICES WITHOUT AN ALLEGED COMPLAINT CONDITION. THE PART NUMBERS WERE IDENTIFIED BASED ON THE ETCHINGS ON THE CORTEX SCREW AND THE FEATURES AND LENGTH ON THE LOCKING SCREWS WITH RESPECT TO RELEVANT DRAWINGS. UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THESE DEVICES CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THESE DEVICES. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. THE RETURNED PLATE AND SCREWS ARE BOTH PART OF THE 2.7MM/3.5MM VA-LCP ANKLE TRAUMA SYSTEM. THE PROVIDED X-RAYS DISPLAYED TWO IMPLANTED PLATES. THE FIRST TWO IMAGES ARE LIKELY PRIOR TO THE PLATE BREAKING AS NO PLATE BREAKAGE WAS OBSERVED. THE SECOND TWO IMAGES SHOW A COMPLETE BREAK THOUGH THE DISTAL COMBI-HOLE. THE FRACTURE SURFACES OF THE PLATE WERE EXAMINED AND SHOW FLATTENING CONSISTENT WITH PRESSURE BETWEEN THE TWO SURFACES AFTER THE BREAK. THE THREADS OF THE BROKEN COMBI-HOLE DO NOT SHOW WEAR CONSISTENT WITH HAVING HELD A SCREW. THUS, THE HOLE WAS LIKELY UNOCCUPIED AT THE TIME OF THE BREAK AS REPORTED. THE BALANCE OF THE PLATE SHOWS SURFACE WEAR CONSISTENT WITH IMPLANT AND EXPLANT. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE PLATE IS ALREADY BROKEN. RELEVANT DRAWINGS WERE REVIEWED. THE PLATE WAS INSPECTED OUTSIDE THE NOTED DAMAGE PER THE DRAWING. THE THICKNESS AT THE PORTION OF THE SHAFT DIRECTLY DISTAL TO BREAK AND THE WIDTH AT THE LOCKING HOLE DIRECTLY DISTAL TO THE HOLE WITH THE BREAK WERE MEASURED AND FOUND TO BE WITHIN THE SPECIFICATION. THE LOCKING HOLE CONTAINING THE BREAK COULD NOT BE FURTHER INSPECTED DUE TO THE DAMAGE. AS THE CIRCUMSTANCES AT THE TIME OF THE ISSUE AND OVER THE LIFESPAN OF THE IMPLANT ARE UNKNOWN A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. FOR EXAMPLE, IF THERE IS INSUFFICIENT REDUCTION OR HEALING IS DELAYED THERE ARE INCREASED LOADS THE IMPLANT MUST WITHSTAND, THAT WOULD NORMALLY BE SUPPORTED BY THE BONE, WHICH COULD EVENTUALLY CAUSE IT TO BREAK DUE TO METAL FATIGUE. THIS IS FURTHER IMPACTED BY PATIENT COMPLIANCE AND ACTIVITY LEVEL, COMORBIDITIES, AND THE SURGICAL TECHNIQUE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SUBJECT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS UNDERGOING INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE PENDING COMPLETION AND WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. 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 PRODUCT CODE: HWC. (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCE 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. PART MFG DATE: 08DEC2015. PART EXP. DATE: 01NOV2025. MANUFACTURING LOCATION: (B)(4). 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

    CONCOMITANT DEVICE REPORTED: CORTEX SCREW Ø 3.5MM, SELF-TAPP., L 32MM (PART 204.832, LOT L115076, QUANTITY 1); VARIABLE-ANGLE LOCKING SCREW STARDRIVE (PART 02.211.034, LOT UNKNOWN, QUANTITY 1); VARIABLE-ANGLE LOCKING SCREW STARDRIVE (PART 02.211.040, LOT UNKNOWN, QUANTITY 2); VARIABLE-ANGLE LOCKING SCREW STARDRIVE (PART 02.211.042, LOT UNKNOWN, QUANTITY 1); VARIABLE-ANGLE LOCKING SCREW STARDRIVE (PART 02.211.044, LOT UNKNOWN, QUANTITY 1); VARIABLE-ANGLE LOCKING SCREW STARDRIVE (PART 02.211.048, LOT UNKNOWN, QUANTITY 1); VARIABLE-ANGLE LOCKING SCREW STARDRIVE (PART 02.127.132, LOT UNKNOWN, QUANTITY 2); VARIABLE-ANGLE LOCKING SCREW STARDRIVE (PART 02.127.134, LOT UNKNOWN, QUANTITY 1).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT SURGERY FOR ANKLE FIXATION ON (B)(6) 2017 THAT INCLUDED IMPLANT OF A VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) ANTEROLATERAL DISTAL TIBIA PLATE. ON UNKNOWN DATE WHILE PATIENT WAS WALKING AROUND AT HOME, THE PLATE BROKE AT AN UNOCCUPIED SCREW HOLE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 WHERE SURGEON REMOVED THE BROKEN PLATE AND REVISED PATIENT TO A HIND-FOOT NAIL IN THE ANKLE JOINT. THIS REPORT IS FOR ONE (1) VA LCP DISTAL TIBIA PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426939 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/10 H/RT-STER PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 9951483

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention