BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP DHP 2.7/3.5 LAT LE SHORT 1-HO L69

    MDR report key: 7345969 · Received March 16, 2018

    Report

    Report Number
    2939274-2018-51088
    Event Type
    Malfunction
    Date Received
    March 16, 2018
    Date of Event
    February 16, 2018
    Report Date
    February 16, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982037480
    PMA / PMN Number
    K120070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH 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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 02.117.901, LOT NUMBER: 7798901, PART MANUFACTURE DATE: 22 SEPTEMBER 2014, MANUFACTURING LOCATION: ELMIRA SYNTHES USA, PART EXPIRATION DATE: N/A, NONCONFORMANCE NOTED: N/A: RELEASE TO WAREHOUSE DATE: 28 JAN 2014, MANUFACTURED BY SYNTHES MONUMENT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 2.7MM/3.5MM VA-LCP LAT DISTAL HUMERUS 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. A 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. 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. H3, H6: A PRODUCT INVESTIGATION WAS PERFORMED. VISUAL INSPECTION UNDER 5X MAGNIFICATION AT CUSTOMER QUALITY (CQ) REVEALED NO ABNORMALITIES OR DAMAGE TO THE 2 DISTAL LOCKING HOLES ON THE RETURNED PLATE. THE RETURNED CONCOMITANT LOCKING SCREWS SUCCESSFULLY THREADED INTO THESE HOLES (SCREW HEAD THREAD) WHEN INSERTED WITHIN THE 30 DEGREE CONE AS REQUIRED BY THESE VARIABLE ANGLE (VA) LOCKING SCREWS. THIS COMPLAINT WAS NOT ABLE TO BE CONFIRMED. THE REPORTED COMPLAINT CONDITION WAS NOT ABLE TO BE REPLICATED AT CUSTOMER QUALITY (CQ) WITH A FUNCTIONAL TEST. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 2.7MM/3.5MM VA-LCP LAT DISTAL HUMERUS PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THE MATERIAL WAS DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE BASED ON REVIEW OF THE DHR. TABULATED PRODUCT DRAWING 02_117_801 MADE TO REVISION H AND CURRENT REVISION J FOR THE FAMILY OF 2.7MM/3.5MM VA-LCP LATERAL DISTAL HUMERUS PLATES WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE RETURNED PLATE IS AN IMPLANT IN THE 2.7MM/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) ELBOW SYSTEM INTENDED FOR FIXATION OF FRACTURES OF THE DISTAL HUMERUS, OLECRANON, AND ULNA IN ADULTS AND ADOLESCENTS (12-21) IN WHICH THE GROWTH PLATES HAVE FUSED. AN IMPORTANT NOTE FOR VARIABLE ANGLE TECHNOLOGY...THE SCREW ANGULATION MUST BE WITHIN 30 DEGREE CONE IN ORDER TO ENSURE PROPER LOCKING OF THE SCREW HEAD THREAD TO THE PLATE HOLE THREAD. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. IT IS POSSIBLE THAT THE USER ATTEMPTED SCREW INSERTION WITHOUT THE VARIABLE ANGLE GUIDE (OUTSIDE OF 30 DEGREE CONE WINDOW) PREVENTING ADEQUATE LOCKING. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AT CQ BECAUSE BASED ON THE DHR REVIEW, 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. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 INFORMATION IS UNKNOWN. ADDITIONAL CLASSIFICATION CODE: HWC. IMPLANT DATE IS UNKNOWN. EXPLANT DATE IS UNKNOWN. THERAPY DATE OF CONCOMITANT DEVICE IS UNKNOWN. A DEVICE HISTORY RECORD REVIEW WAS REQUESTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. DEVICE IS A SINGLE USE DEVICE BUT WAS NOT REPROCESSED OR REUSED. 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 DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A DISTAL HUMERUS FRACTURE (INITIAL SURGERY) ON (B)(6) 2018, THE TWO DISTAL LOCKING HOLES ON A VARIABLE ANGLE LOCKING COMPRESSION (VA-LCP) DISTAL PLATE WERE STRIPPED AND WILL NOT ACCEPT ANY LOCKING SCREWS. THE 2 DISTAL LOCKING SCREWS DID NOT HAVE ANY VISIBLE MALFUNCTION ON THEM. SURGEON OPTED TO USE VA-LCP DISTAL PLATE AND 2 DISTAL LOCKING SCREWS FROM ANOTHER SET WHICH WAS EASILY ACCESSIBLE IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY NOR ANY IMPACT TO PATIENT. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. CONCOMITANT PARTS REPORTED: PRODUCT CODE: 2.7 MM LOCKING SCR,14 MM LOT # :UNKNOWN. PRODUCT CODE: 2.7 MM LOCKING SCR 16 MM LOT # :UNKNOWN. PRODUCT CODE: 2.7 NON-LCKNG SCR, 26 MM LOT # :UNKNOWN. PRODUCT CODE: 2.7 MM LOCKING SCR, 28 MM LOT # :UNKNOWN. PRODUCT CODE: 2.7 MM LOCKING SCR, 30 MM LOT # :UNKNOWN. PRODUCT CODE: 2.7 MM LOCKING SCR,32 MM LOT # :UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189989 VA-LCP DHP 2.7/3.5 LAT LE SHORT 1-HO L69 PLATE,FIXATION,BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.117.901 7798901 10886982037480

    Patients

    Seq Age Sex Outcome Treatment
    1