BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/125 DEG TI CANN TFNA 420MM/RIGHT - STERILE

    MDR report key: 7485010 · Received May 3, 2018

    Report

    Report Number
    8030965-2018-53524
    Event Type
    Injury
    Date Received
    May 3, 2018
    Report Date
    April 12, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819649866
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. ADDITIONAL NARRATIVE: A5: PATIENT ETHNICITY IS UNKNOWN. D11: DATE OF CONCOMITANT THERAPY IS KNOWN. H3, H4, H6: MANUFACTURING LOCATION: MONUMENT; MANUFACTURING DATE: JANUARY 12, 201; EXPIRATION DATE: DECEMBER 31, 2026; PART: 04.037.032S, LOT: H247424 (STERILE) - 10MM/125 DEG TI CANN TFNA 420MM/RIGHT - STERILE. QUANTITY 5. COMPONENT PARTS REVIEWED: PART 04.037.912.2 - LOCK PRONG, 130 DEGREE, TFNA BP-55 LOT - L096107 , PART 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - 9937550 , PART 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT - H202418 , PART 21127 - RAW MATERIAL LOT BP-80 LOT - H123944. RAW MATERIAL FOR TITANIUM RECEIVED FROM METALWERKS PMD, CERTIFICATE OF ANALYSIS FOR TITANIUM RECEIVED FROM METALWERKS MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL AND INSPECTION SHEET FOR TFNA ASSEMBLY INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ETHICON (ABQ), ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ CUSTOMER QUALITY INVESTIGATION: THE FOLLOWING INVESTIGATIONS WERE PERFORMED: BROKE VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY OBSERVED THAT THE NAIL WAS BROKEN AT THE PORTION WHERE THE CONNECTION SCREW ENGAGES. NO OTHER ISSUES WERE IDENTIFIED ON THE REMAINING PORTIONS OF THE DEVICE. ALSO, NO NEW ISSUES WERE IDENTIFIED ON THE CONCOMITANT DEVICES (TFNA SCREW AND 2 LOCKING SCREWS WITH STAR DRIVE RECESS) EXCEPT FOR THE MINOR WORN THREAD SURFACES ON 2 LOCKING SCREWS WHICH COULD POSSIBLY BE THE RESULT OF SCREW REMOVAL PROCESS. THE COMPLAINT CONDITION AGREES WITH THE COMPLAINT DESCRIPTION. THEREFORE, THE COMPLAINT CONDITION WAS CONFIRMED. DRAWINGS (MFG. AND CURRENT) WERE REVIEWED AND WERE DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. DIMENSIONAL ANALYSIS PERFORMED ON THE SHAFT DIAMETER AT THE BROKEN REGION MEASURED 15.71 MM (CA-814); THAT FALLS WITHIN THE SPECIFICATION OF 15.56 MM TO 15.76 MM. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED IMPLANT¿S LOT NUMBER AND NO NCRS, MATERIAL REVIEW REPORTS (MRRS) OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ALSO, BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT ANY ISSUES WITH MATERIAL OR MATERIAL PROPERTIES CONTRIBUTED TO THE COMPLAINT CONDITION. THE DCRM DOCUMENT TFNA REVIEWED DURING INVESTIGATION COMPLETELY ADDRESSES THE GIVEN COMPLAINT CONDITION RISK. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS LIKELY THAT ANY UNINTENDED FORCES ENCOUNTERED BY THE DEVICE WITH PATIENT¿S POST-OP ACTIVITIES COULD HAVE CONTRIBUTED TO THE GIVEN COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUE OR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION WERE OBSERVED. THEREFORE, NO FURTHER CORRECTIVE AND PREVENTIVE ACTIONS ARE 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

    ADDITIONAL PATIENT IDENTIFIER: (B)(6). PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF EVENT: DATE OF DEVICE BREAKAGE IS NOT KNOWN. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) RIGHT NAIL, TFNA FENESTRATED SCREW, AND TWO (2) 5.0MM LOCKING SCREWS ON (B)(6) 2018. ON UNKNOWN DATE IT WAS DETERMINED THE NAIL HAD BROKEN. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. PATIENT WAS REVISED TO A COMPETITOR¿S CONSTRUCT. CONCOMITANT DEVICES REPORTED: TFNA FENESTRATED SCREW 100MM (04.038.200S, LOT H406655, QUANTITY 1); 5.0MM LOCKING SCREW 50MM FOR IM NAIL (04.005.540S, LOT L593979, QUANTITY 1): 5.0MM LOCKING SCREW 58MM FOR IM NAIL (04.005.548S, LOT 9667608, QUANTITY 1). THIS REPORT IS FOR ONE (1) 10MM 125 DEGREE CANNULATED TFNA NAIL 420MM-RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328116 10MM/125 DEG TI CANN TFNA 420MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H247424 07611819649866

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention THERAPY DATE: (B)(6) 2018