BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM (TI) RIB SLEEVE-SIZE 8 220MM RADIUS

    MDR report key: 7789646 · Received August 16, 2018

    Report

    Report Number
    8030965-2018-55758
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Report Date
    May 16, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MDI
    UDI-DI
    07611819747135
    PMA / PMN Number
    K142587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. DHR REVIEW WAS COMPLETED. PART NUMBER: 497.107. LOT NUMBER: 7002855. DATE OF MANUFACTURE: 16-AUG-2012. PLACE OF MANUFACTURE: RMS (BRANDYWINE). PART EXPIRATION DATE: NONE. LIST OF NONCONFORMANCES: NONE. DESCRIPTION OF DHR REVIEW: NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DHR REVIEW OF RAW MATERIAL REVEALED THIS LOT MET ALL SPECIFICATION WITH NO NONCONFORMITIES 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. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. US CUSTOMER QUALITY (CQ) INVESTIGATION WORKFLOW: BROKEN. VISUAL INSPECTION: VISUAL INSPECTION PERFORMED AT CQ OF THE RETURNED RIB SLEEVE REVEALED THE DEVICE BROKE AT THE MOST INFERIOR HOLE, JUST DORSAL TO THE INTERIOR LIP THAT INTERFACES WITH A LUMBAR EXTENSION (497.131-4; 497.251-4), WHICH IS RESPONSIBLE FOR PROPER ASSEMBLY OF THESE TWO DEVICES. THE DEVICE WAS RECEIVED ASSEMBLED TO A DISTRACTION LOCK (497.125/LOT# H243898) AT THE SECOND-MOST INFERIOR HOLE. MINOR NICKS WERE OBSERVED THAT ARE CONSISTENT WITH IMPLANTATION/EXPLANTATION. THE RECEIVED CONDITION OF THE DEVICE AGREES WITH THE COMPLAINT CONDITION OF BROKEN. BASED ON VISUAL INSPECTION, THE CONDITION OF THE DEVICE IS CONFIRMED TO BE BROKEN. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RIB SLEEVE COULD NOT BE CONDUCTED DUE TO THE BROKEN CONDITION OF THE DEVICE AT THE RELEVANT FEATURE. DOCUMENT/SPECIFICATION REVIEW: DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, INCLUDING THE MATERIALS AND ITS PROPERTIES, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED DURING THE INVESTIGATION: TOP LEVEL DRAWINGS FOR THE RIB SLEEVE (CURRENT AT THE TIME OF MANUFACTURE) AND (CURRENT AT THE TIME OF THIS INVESTIGATION). DURING THE INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION OF BROKEN WAS CONFIRMED DURING INVESTIGATION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. WHILE A ROOT CAUSE COULD NOT BE DETERMINED, IT IS POSSIBLE THE DEVICE EXPERIENCE EXCESSIVE FORCES DURING USE THAT CONTRIBUTED TO THE BROKEN CONDITION. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE 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 NOT AVAILABLE FOR REPORTING. DATE OF POSTOPERATIVE DEVICE BREAKAGE IS UNKNOWN. UNKNOWN IF THE DEVICE WAS IMPLANTED DURING (B)(6) 2014 SURGERY OR DURING (B)(6) 2017 SURGERY. CONCOMITANT MEDICAL PRODUCTS: THERAPY DATE IS EITHER (B)(6) 2014 OR (B)(6) 2017. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2014, THE SURGERY FOR INFANT SCOLIOSIS WAS PERFORMED TO FIX THE THORACOLUMBAR BY USING THE VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTER) SYSTEM. FOLLOWING CONTINUOUS EXTENSION SURGERIES, A FULL EXTENSION SURGERY WAS PERFORMED ON (B)(6) 2017. AROUND (B)(6) 2018, IT WAS CONFIRMED UNDER THE X-RAY THAT THE EXTENSION BAR AND ROD HAD COME OFF DUE TO THE POSSIBILITY OF THE CLOSURE BEING DETACHED. ON (B)(6) 2018, DURING THE PLANNED REVISION SURGERY, PART OF THESE IMPLANTS WAS CONFIRMED TO HAVE BEEN BROKEN WHEN EXTRACTED. THE BREAKAGE OCCURRED BEFORE THE REVISION SURGERY. ALL THE IMPLANTS AS WELL AS THE BROKEN PART WERE EXTRACTED AND THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES: TI LUMBAR EXTENSION SIZE 8/220MM RADIUS (PART # 497.133, LOT # 6032046, QUANTITY 1); TI DISTRACTION LOCK (PART # 497.125, LOT # H243898, QUANTITY 1). THIS REPORT IS FOR A TITANIUM (TI) RIB SLEEVE-SIZE 8 220MM RADIUS. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630606 TITANIUM (TI) RIB SLEEVE-SIZE 8 220MM RADIUS PROSTHESIS, RIB REPLACEMENT MDI OBERDORF SYNTHES PRODUKTIONS GMBH 7002855 07611819747135

    Patients

    Seq Age Sex Outcome Treatment
    1