BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANTA PARTIALLY THREADED 5MM SCREW - 25MM LENGTH

    MDR report key: 4934568 · Received July 21, 2015

    Report

    Report Number
    9615741-2015-00036
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    May 30, 2015
    Report Date
    June 25, 2015
    Manufacturer
    NEWDEAL SAS
    Product Code
    HSB
    PMA / PMN Number
    K091788
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(6) 2015. THE ADDITIONAL INVESTIGATION ACTIVITIES INCLUDED: METHODS: -REVIEW OF DEVICE HISTORY RECORDS. -REVIEW OF COMPLAINT HISTORY. RESULTS: A REVIEW OF THE DESIGN SPECIFICATIONS AND DESIGN CHANGES WAS PERFORMED. NO SIGNIFICANT DESIGN CHANGE WAS DONE ON DIMENSIONS OR RAW MATERIAL ON SPECIFICATIONS DURING THE LAST TWO YEARS. A REVIEW OF THE DEVICE HISTORY CANNOT BE PERFORMED AS NO LOT NUMBER IS PROVIDED TO NEWDEAL. A REVIEW OF THE COMPLAINT SYSTEM WAS PERFORMED. THIS IS THE FIRST INCIDENT (TWO SCREWS ARE CONCERNED) REPORTED TO NEWDEAL ABOUT A BREAKAGE OF A PANTA® NAIL PARTIALLY THREADED SCREW DIAMETER 5MM FOR THE PAST TWO YEARS. DURING THE SAME TIME PERIOD, ABOUT 5 031 PANTA® NAIL PARTIALLY THREADED SCREWS DIAMETER 5MM WERE SOLD. THE COMPLAINT RATE FOR THIS KIND OF INCIDENT DURING THE STATED TIME PERIOD IS 0.0398 PERCENT. LOT FAILURE RATE CANNOT BE CALCULATED AS NO LOT NUMBER IS PROVIDED. CONCLUSION: GIVEN THE DESCRIPTION OF THE EVENT AND THE OBSERVATIONS MADE DURING THE INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT CANNOT BE DETERMINED AS NO LOT NUMBER WAS PROVIDED AND NO PRODUCT WAS RETURNED FOR ANALYSIS. NO ANOMALY WAS FOUND DURING DOCUMENTARY INVESTIGATION.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PANTA SCREWS BROKE AND THE PATIENT WOULD NEED REVISION SURGERY DUE TO THE DEVICES BREAKING. THERE ARE 2 PRODUCTS, 4 LOTS ASSOCIATED WITH THIS EVENT. TWO ADDITIONAL REPORTS WILL BE SUBMITTED TO CAPTURE THE 2 ADDITIONAL LOTS. THIS IS REPORT 2 OF 4 SUBMISSIONS FOR THIS EVENT. ADDITIONAL INFORMATION RECEIVED 21SEP2015: REVISION SURGERY OCCURRED (B)(6) 2015. THE BROKEN SCREWS WERE REMOVED AND COLLECTED FOR RETURN. PRODUCT ID UPDATED.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 12/04/2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE, REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINTS HISTORY. RESULTS: PRODUCTS WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED. ANOMALIES WERE OBSERVED. SCREWS P/N 511065S & 511070S WERE BREAKAGE AT THE SHAFT DIAMETER. NO ANOMALY WAS OBSERVED FOR P/N 511025S. A MEASUREMENT INSPECTION WAS PERFORMED. NO ANOMALY WAS OBSERVED. SHAFT DIAMETER Ø5MM WAS MEASURED FOR EACH BROKEN SCREWS. FOR P/N 511065S THE SHAFT DIAMETER WAS MEASURED AT 4,90MM. FOR P/N 511070S THE SHAFT DIAMETER WAS MEASURED AT 4,92MM. BOTH DIAMETERS ARE IN COMPLIANCE WITH NEWDEAL SPECIFICATIONS Ø5 (0/-0, 15 MM). NO ANOMALY WAS OBSERVED FOR THE PANTA NAIL 500180S. A REVIEW OF THE DEVICE HISTORY RECORD IS PERFORMED FOR P/N 511065S. MANUFACTURING LOT NUMBER F3HB WAS MANUFACTURED IN APRIL 2012. NO ANOMALY WAS DETECTED REGARDING THE INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD IS PERFORMED FOR P/N 511025S. MANUFACTURING LOT NUMBER F4NK WAS MANUFACTURED IN FEBRUARY 2013. NO ANOMALY WAS DETECTED REGARDING THE INCIDENT. A REVIEW OF THE DEVICE HISTORY CANNOT BE PERFORMED FOR P/N511070S AS NO LOT NUMBER IS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD IS PERFORMED FOR P/N 500180S. MANUFACTURING LOT NUMBER F33C WAS MANUFACTURED IN DECEMBER 2012. NO ANOMALY WAS DETECTED REGARDING THE INCIDENT. A REVIEW OF THE COMPLAINT SYSTEM WAS PERFORMED. THIS IS THE FIRST INCIDENT (THREE SCREWS ARE CONCERNED AND A PANTA NAIL ) REPORTED ABOUT A BREAKAGE OF A PANTA® NAIL PARTIALLY THREADED SCREW DIAMETER 5MM FOR THE PAST TWO YEARS. DURING THE SAME TIME PERIOD, ABOUT 5604 PANTA® NAIL PARTIALLY THREADED SCREWS DIAMETER 5MM WERE SOLD. THE COMPLAINT RATE FOR THIS KIND OF INCIDENT DURING THE STATED TIME PERIOD IS (B)(4) PERCENT. CONCLUSION: GIVEN THE DESCRIPTION OF THE EVENT AND THE OBSERVATIONS MADE DURING THE INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT CANNOT BE DETERMINED. REGARDING THE OBSERVATION MADE DURING THIS INVESTIGATION, THE PANTA NAIL INVOLVED IN THIS CASE IS NOT RELATED TO THE CAUSE OF INCIDENT. NO ANOMALY WAS OBSERVED DURING FAILURE ANALYSIS AND REVIEW OF QUALITY RECORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WILL NEED REVISION SURGERY DUE TO THE DEVICES BREAKING. THIS IS THE SECOND OF TWO RELATED REPORTS. IT WAS REPORTED THE PANTA NAIL SYSTEM WAS IMPLANTED 5 MONTHS PRIOR TO THIS EVENT. THE PT RECENTLY RETURNED TO THE SURGEON WITH SEVERE FOOT PAIN. IT WAS OBSERVED THAT BOTH THE CALCANEAL SCREWS BROKE AND ALSO TALUS BONE COMPRESSION AT UNHEATED SURGICAL SITE. THE DEVICES WERE IMPLANTED ON (B)(6) 2014. THE EVENT WAS OBSERVED ON (B)(6) 2015. A SECOND SURGERY WILL BE PERFORMED AFTER RAMADAN, (B)(6) 2015. THE PT HAD SYMPTOMS OF SEVERE PAIN AND NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470700 PANTA PARTIALLY THREADED 5MM SCREW - 25MM LENGTH N/A HSB NEWDEAL SAS F4NK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention