BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA-LCP DRSL DSTL RAD L-PLATE +90°/3H HD/3H SHAFT

    MDR report key: 8436246 · Received March 20, 2019

    Report

    Report Number
    8030965-2019-62100
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Report Date
    February 25, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819422919
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. VISUAL INSPECTION: THE VA-LCP DORSAL DISTAL RADIUS L-PLATE IS BROKEN AS COMPLAINED. THE BREAKAGE OCCURRED AT THE VA2 HOLE; IT IS VISIBLE THAT THE PLATE GOT BENT BEFORE BREAKING. ON THE PLATE SURFACE THERE ARE SLIGHT MARKS AND SOME DISCOLORATION VISIBLE. THE FRACTURE SURFACE IS TYPICAL FOR A FORCED FRACTURE. THE IMPLANT WAS RECEIVED WITHOUT ORIGINAL PACKAGE. DIMENSIONAL INSPECTION: RELEVANT DIMENSION ¿PLATE THICKNESS WAS CHECKED AND FOUND TO COMPLY WITH THE SPECIFICATIONS. PLATE THICKNESS AT THE AREA OF THE BREAKAGE IS 2.04 MM. MATERIAL REVIEW: THE CERTIFICATE OF THE RAW MATERIAL WAS REVIEWED DURING THE PERFORMED DEVICE HISTORY REVIEW; THIS LOT MET ALL SPECIFICATIONS WITH NO NONCONFORMANCES NOTED. THE VA-LCP DORSAL DISTAL RADIUS L-PLATE IS MADE FROM PURE TITANIUM (TICP). SUMMARY: THE COMPLAINT CONDITION IS CONFIRMED AS THE VA-LCP DORSAL DISTAL RADIUS L-PLATE IS BROKEN. THIS PRODUCTION LOT (L844872) WAS MANUFACTURED IN APRIL 2018 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THE INVESTIGATION FOUND NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. THE GIVEN INFORMATION INDICATES THAT THE PLATE WAS FOUND BROKEN UPON UNPACKING. THE PERFORMED INSPECTION SHOWED THAT THE PLATE WAS SUBJECTED TO SOME BENDING MOMENTS BEFORE BREAKING. IN ADDITION, MARKS AND SLIGHT DISCOLORATION ON THE PLATE SURFACE WERE NOTED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCE SURROUNDING THE EVENT IS UNKNOWN. THE RECEIVED CONDITION IS CONSISTENT WITH BENDING AND SUBSEQUENT BREAKAGE DUE TO A MECHANICAL OVERLOAD ¿ UNKNOWN IF THIS HAPPENED DURING TRANSPORTATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT: PART: 04.115.230; LOT: L844872; MANUFACTURING SITE: (B)(4); RELEASE TO WAREHOUSE DATE: 13 APRIL 2018. LOT L844872 WAS MANUFACTURED FROM BLANK 60063169 LOT L601191; MANUFACTURING SITE: (B)(4); RELEASE TO WAREHOUSE: 27 SEP 2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE VARIABLE ANGLE LOCKING COMPRESSION PLATE WAS FOUND CRACKED WHEN UNPACKING. THE PLATE WAS ALREADY DELIVERED WITH DAMAGE. THE ISSUE WAS DISCOVERED OUTSIDE OF THE OPERATION THEATER. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.4MM TI VA-LCP DRSL DSTL RAD L-PLATE +90°/3H HD/3H SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230843 2.4MM TI VA-LCP DRSL DSTL RAD L-PLATE +90°/3H HD/3H SHAFT PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH L844872 07611819422919

    Patients

    Seq Age Sex Outcome Treatment
    1