BEUDAMED
    FDA Adverse Event Injury Summary report: N

    95 DEG DCS® PLATE 6 HOLES/114MM

    MDR report key: 8571045 · Received May 1, 2019

    Report

    Report Number
    8030965-2019-63358
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    April 2, 2019
    Report Date
    April 2, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819013063
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    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. ADDITIONAL EVENT DESCRIPTION FACILITY INFORMATION A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 281.960 LOT NUMBER: 6934582 PART MANUFACTURE DATE: 08-MAY-2012 MANUFACTURING LOCATION: ELMIRA PART EXPIRATION DATE: N/A NONCONFORMANCE NOTED: N/A DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 95 DEG DCS PLATE 6 HOLES/114MM 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. ACTUAL DEVICE WAS NOT RECEIVED AT CUSTOMER QUALITY AS OF JUNE 10, 2019. VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY (CQ) OF THE COMPLAINT DEVICE IN COMPLAINT FILE ATTACHMENT CONFIRMED THE CONDITION OF PLATE BREAKAGE, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. THE PHOTOS SHOW THAT THE TRANSVERSE BREAK OCCURRED AT THE 4TH MOST DISTAL HOLE. FURTHER INFORMATION REGARDING THE BREAK PROFILE COULD NOT BE DETERMINED BASED SOLELY ON THE PROVIDED PHOTOS. THE RECEIVED PHOTO CONDITION DOES AGREE WITH THE COMPLAINT DESCRIPTION. THE COMPLAINT IS CONFIRMED. THE CAUSE OF THE ISSUE WAS NOT DETERMINED TO BE USE ERROR, MISUSE/ABUSE, NON-COMPLIANCE, POST OPERATIVE TRAUMA. MANUFACTURING RECORD EVALUATION: THE COMPLAINT DEVICE WAS MANUFACTURED IN 2012. 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. DOCUMENT/SPECIFICATION REVIEW: TABULATED DESIGN DRAWINGS FOR THE FAMILY OF 95 DEGREE DCS-PLATES WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. INVESTIGATION CONCLUSION: A DEFINITIVE ASSIGNABLE ROOT CAUSE FOR THE PLATE BREAKING POST OPERATIVELY COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 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.

    Description of Event or Problem · 0

    IT WAS ALSO REPORTED THAT THERE WAS NO FUSION BETWEEN THE PLAQUE AND THE BONE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRO-CODE: KTT. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF THE DYNAMIC CONDYLAR SCREW (DCS ) PLATE IMPLANT IN THE PROXIMAL FEMUR DUE TO THE BROKEN PLATE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: DHS/DCS LAG SCREW (PART #: 280.650, LOT#: 2212404, QUANTITY #1), DHS/DCS COMPRESSION SCREW (PART #: 280.990, LOT #: 3526974, QUANTITY # 1), UNKNOWN SCREWS (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 4). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363482 95 DEG DCS® PLATE 6 HOLES/114MM PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH 6934582 07611819013063

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention DHS®/DCS® COMPRESSION SCREW 36MM.| DHS®/DCS® LAG SCREW 12.7MM THREAD/65MM.| UNK - SCREWS: TRAUMA.