BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 4H-STER

    MDR report key: 9377755 · Received November 26, 2019

    Report

    Report Number
    2939274-2019-62397
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 8, 2019
    Report Date
    November 8, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    UDI-DI
    10886982178701
    PMA / PMN Number
    K033556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. THE 135 DEG LCP DHHS(TM) SIDEPLATE-STD BARREL 4 HOLES (P/N: 282.612, LOT #: 4932237) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THAT IT IS STUCK WITH ANOTHER RECEIVED DEVICE AND IS UNABLE TO BE DISASSEMBLED. NO OTHER DAMAGE IS NOTED. NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO THE NATURE OF THE COMPLAINT AND DEVICE RECEIVED CONDITION. THIS COMPLAINT IS CONFIRMED AS COMPLAINT DEVICE CANNOT BE DISASSEMBLED FROM ITS MATING DEVICE. HOWEVER, THE DEVICES ARE ASSEMBLED, THEREFORE THE UNABLE TO ASSEMBLE COMPLAINT IS NOT CONFIRMED. NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT. PART NUMBER: 282.612S. LOT NUMBER: 4932237. PART MANUFACTURE DATE: 07-MAR-2005. MANUFACTURING LOCATION: (B)(4). PART EXPIRATION DATE: 31-JAN-2014. NONCONFORMANCE NOTED: (B)(4). DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) DEG LCP DHHS SIDEPLATE-STD BARREL 4H-STER PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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

    REPORTER IS A SYNTHES EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4).  THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR USING A DYNAMIC HELICAL HIP SYSTEM (DHHS). THE HELICAL/HELIX BLADE WAS INSERTED IN A NORMAL FASHION. AS THE SURGEON WENT TO KEY IN THE HELICAL BLADE, THE HELICAL BLADE OVER-INSERTED. WHEN THE SURGEON TRIED TO BACK UP THE HELICAL BLADE, IT WOULD NOT SLIDE THROUGH THE PLATE/SIDE PLATES STANDARD BARREL. THE HELICAL BLADE AND THE PLATE WERE REMOVED IN A SINGLE PIECE AND A NEW HELICAL BLADE AND PLATE WERE REINSERTED WITHOUT INCIDENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170759 135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 4H-STER APPLIANCE,FIXATION,NAIL KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 282.612 4932237 10886982178701

    Patients

    Seq Age Sex Outcome Treatment
    1