BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 7142278 · Received December 22, 2017

    Report

    Report Number
    8030965-2017-50948
    Event Type
    Injury
    Date Received
    December 22, 2017
    Report Date
    November 28, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW THIS REPORT IS NOW PRODUCT PROBLEM AND SERIOUS INJURY. THIS COMPLAINT WAS RE-REVIEWED DUE TO THE INVESTIGATION FINDINGS. THE NAIL LOCKING MECHANISM COMPONENT WAS IDENTIFIED TO BE BROKEN. DURING THE INITIAL PROCEDURE THE NAIL DID NOT FUNCTION PROPERLY AND THE BLADE WAS NOT FULLY INSERTED. IT WAS DETERMINED THAT THE INTRA-OPERATIVE MALFUNCTIONS CAUSED OR CONTRIBUTED TO THE REPORTED POST-OPERATIVE CONSEQUENCES THAT RESULTED IN THE BLADE MIGRATING POST-OPERATIVE AND PAIN. IT IS ASSUMED THAT THE LOCKING MECHANISM COMPONENT WAS BROKEN AND THAT IS WHY DURING THE INITIAL PROCEDURE THAT IT WAS NOT ¿WORKING PROPERLY¿. MEDICAL/SURGICAL INTERVENTION REQUIRED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 NARRATIVE: DEVICE HISTORY RECORDS (DHR) REVIEW WAS COMPLETED FOR PART# 04.037.242S, LOT# 9960976. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JAN 07, 2016, EXPIRY DATE: DEC 31, 2025. PART #: 04.037.242S, LOT#: 9960976 (STERILE) - 12MM/130 DEG TI CANN TFNA 170MM - STERILE. QUANTITY 6. COMPONENT PARTS REVIEWED: PART 04.037.942.2 - LOCK PRONG, 130 DEGREE, TFNA BP-55 LOT - 9708107; PART 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT ¿ 7921065; PART 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT ¿ 9946105. PART 21127 - RAW MATERIAL LOT BP-80 LOT - 9814907. RAW MATERIAL RECEIVED FROM SUPPLIER (B)(4). CERTIFICATE OF ANALYSIS RECEIVED FOR TITANIUM FROM (B)(4). MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. INSPECTION SHEET FOR TFNA ASSEMBLY INSPECTION AND INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL MET INSPECTION ACCEPTANCE CRITERIA. 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. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE RETURNED NAIL (PART 04.037.242S, LOT 9960976, MFG. 07-JAN-2016) WAS INSPECTED AT CUSTOMER QUALITY AND THE COMPLAINT WAS CONFIRMED. REPLICATION IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE LOCKING MECHANISM TANG WAS BOTH BENT AND BROKEN. THE DAMAGE IS CONSISTENT THE LOCKING MECHANISM BEING PRE-DEPLOYED AND BEING STRUCK BY THE INSERTED HELICAL BLADE FOLLOWED BY FURTHER UNSUCCESSFUL LOCKING ATTEMPTS. DAMAGE TO THE HELICAL BLADE CONFIRMS THIS BASED ON SCRATCHES. ADDITIONALLY, THERE ARE NO WEAR MARKS PRESENT ON THE INFERIOR SURFACE THAT WOULD INTERFACE WITH THE HELICAL BLADE IF PROPERLY ENGAGED. RELEVANT DRAWINGS WERE REVIEWED AND NO DESIGN ISSUES WERE IDENTIFIED. DIMENSIONAL ANALYSIS WAS NOT PERFORMED AS RELEVANT FEATURES ARE SIGNIFICANTLY DEFORMED. MATERIAL AND RELEVANT TESTING OCCURRED AT THE TIME OF MANUFACTURE AND CONFIRMED TO HAVE NO ISSUES THROUGH THE DHR REVIEW. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS LIKELY THAT THE LOCKING MECHANISM WAS PRE-DEPLOYED AND STRUCK BY THE HELICAL BLADE, WHICH LEAD TO THE DAMAGE OF THE LOCKING MECHANISM. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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

    510K: THIS REPORT IS FOR AN TFNA NAIL/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE OF IMPLANT/EXPLANT IS NOT KNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    PATIENT OUTCOME REPORTED AS STABLE FOLLOWING THE REMOVAL SURGERY. THIS COMPLAINT ADDRESSES BLADE INSERTION ISSUE DURING THE INITIAL SURGERY AND ALSO REMOVAL SURGERY DUE TO PAIN. THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 170MM - STERILE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT INITIAL TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) IMPLANT SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE APPROXIMATELY TWO (2) YEARS PRIOR TO REMOVAL. IT WAS FURTHER REPORTED THAT THE HELICAL BLADE WAS NOT FULLY INSERTED DURING THE INITIAL PROCEDURE AND THE LOCKING MECHANISM ON THE NAIL MAY NOT HAVE PROPERLY FUNCTIONED. AFTER BONE ADHESION, PATIENT COMPLAINED OF PAIN IN THE HIP. IT WAS DETERMINED THE HELICAL BLADE HAD PROTRUDED FRONTWARD. REMOVAL SURGERY WAS PERFORMED ON AN UNKNOWN DATE AND COMPLETED SUCCESSFULLY WITH NO FURTHER ISSUE. REMOVAL SURGERY DUE TO PAIN IS ADDRESSED IN(B)(4). THIS REPORT ADDRESSES THE INTRAOPERATIVE ISSUES DURING THE INITIAL PROCEDURE. THIS IS REPORT 2 OF 2 FOR (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921720 12MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF : SYNTHES PRODUKTIONS GMBH 9960976

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention