BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/14 H/LT-STER

    MDR report key: 7014197 · Received November 9, 2017

    Report

    Report Number
    3003506883-2017-10260
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 10, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: UPDATED INFORMATION. THE INVESTIGATION SUMMARY INDICATES THAT: CONCOMITANT PARTS HAS BEEN RECEIVED AND NO INVESTIGATION WILL BE DONE. 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

    DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART MFG DATE: 06 MAY 2016. PART EXP. DATE: 01 APRIL 2026. MANUFACTURING LOCATION: ELMIRA, NEW YORK 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 PL/14 H/LT-STERILE WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH ONE NONCONFORMANCE NOTED. THE NONCONFORMANCE REVIEWED IS NR-0036944 AND IS ASSOCIATED TO LOT H071539. THIS NC WAS GENERATED DUE TO THE SUM OF THE QUANTITY OF LABELS USED FOR PACKAGING, QUANTITY USED ON THE LABEL LABEL LOG, AND QUANTITY DESTROYED NOT BEING EQUAL TO THE FINAL QUANTITY ON THE F-S252 PACKAGING LABEL LOG FORM. THIS NC DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION AS THE COMPLAINT WAS GENERATED DUE TO THE PLATE BREAKING. 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 NONCONFORMANCE 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. A MANUFACTURING INVESTIGATION ACTION WAS CONDUCTED/PERFORMED. THE REPORT INDICATES THAT THE: AS RECEIVED CONDITION OF DEVICE A VISUAL INSPECTION OF THE PART REVEALED NOTICEABLE DINGS AND SCRATCHES ON SHAFT OF THE PLATE. INVESTIGATION: THREADED HOLE. THE QE MEASURED THE FOLLOWING RELEVANT FEATURES AS LISTED ON DIMENSIONAL INSPECTION SHEETS THESE FEATURES ARE SIMILARLY ADJACENT TO THE LOCATION AT WHICH THE PLATE BROKE AND WILL BE MEASURED TO CONFIRM THE RELEVANT THICKNESS, WIDTH, X-CUT WIDTH, AND X-CUT LENGTH MEET SPECIFICATIONS PER DIMENSIONAL INSPECTION SHEETS WILL NOT BE MEASURED AS THEY ARE NOT RELEVANT TO THE COMPLAINT CONDITION. CONCLUSION: THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE FOR SHIPMENT WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION, IT HAS BEEN CONCLUDED ANY DAMAGE, BREAKAGE, GOUGES/SCRATCHES OR OUT OF SPECIFICATION CONDITION DUE TO DAMAGE OCCURRED AFTER THE PRODUCT LEFT MANUFACTURING. SINCE NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, A REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. UDI: (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.

    Additional Manufacturer Narrative · 1

    PATIENT AGE OR DATE OF BIRTH NOT AVAILABLE FOR REPORTING. ADDITIONAL PRODUCT CODE: HWC. (B)(4). DATE OF EXPLANT WAS NOT REPORTED. HOSPITAL TELEPHONE NOT AVAILABLE FOR REPORTING. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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: RECEIVED SOME CONCOMITANT PARTS 8X VA LOCKING SCREWS (ARTICLE AND LOT UNKNOWN); 1X CORTEX SCREW (ARTICLE AND LOT UNKNOWN): AS THOSE PARTS ARE NOT RESPONSIBLE FOR THE BREAKAGE OF THE PLATE, NO INVESTIGATION WILL BE DONE ON THOSE.

    Description of Event or Problem · 1

    UPDATE: THE LOT NUMBER FOR THE PART VA-LCP ANTEROLAT DIST IS IN COMPLAINT ADDED. THE CONCOMITANT 5X VA LOCKING SCREW STARDRIVE/ LOT UNKNOWN, 2X VA LOCKING SCREW STARDRIVE/ LOT UNKNOWN, 1X VA LOCKING SCREW STARDRIVE/ LOT UNKNOWN, 1X CORTEX SCREW Ø 3.5MM / LOT UNKNOWN MATERIAL IS RECEIVED. THE CONCOMITANT 1X VA LOCKING SCREW STARDRIVE/ LOT UNKNOWN ISN¿T RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH THE 2.7/3.5 MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) ANTEROLATERAL DISTAL TIBIA PLATE LEFT AND TEN (10) SCREWS ON (B)(6) 2017. SURGEON PRESCRIBED PATIENT TO BE NON-WEIGHT BEARING FOR EIGHT (8) TO TEN (10) WEEKS POSTOPERATIVE. PATIENT WENT TO REHABILITATION AND WAS MADE TO WALK WITH WEIGHT BEARING AT FIVE (5) TO SIX (6) WEEKS AND THE PLATE BROKE. DUE TO DIABETES PATIENT DID NOT FEEL ANYTHING. CONCOMITANT DEVICES REPORTED: VA LOCKING SCREW (QUANTITY 9), CORTEX SCREW (QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7/3.5 MM VA-LCP ANTEROLATERAL DISTAL TIBIA PLATE 14 HOLE LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794415 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/14 H/LT-STER PLATE, FIXATION, BONE HRS SYNTHES ELMIRA H071539

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CORTEX SCREW (PART AND LOT UNKNOWN, QTY 1))| VA LOCKING SCREW (PART AND LOT UNKNOWN, QTY 9)