BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/125 DEG TI CANN TFNA 200MM - STERILE

    MDR report key: 7287584 · Received February 21, 2018

    Report

    Report Number
    8030965-2018-51294
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    January 24, 2018
    Report Date
    January 24, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819649477
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: 11-NOV-2015, EXPIRATION DATE: 30-NOV-2025: PART #: 04.037.013S (EU ITEM NO.) LOT#: 9938400 (STERILE) - 10MM/125 DEG TI CANN TFNA 200MM - STERILE. QUANTITY 5. COMPONENT PARTS REVIEWED: PART 04.037.912.2 - LOCK PRONG, 125 DEGREE, TFNA. BP-55 LOT - 9610722 (3), 9610737 (2), PART 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT ¿ 7921046, PART 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT ¿ 9903050. PART 21127 - RAW MATERIAL LOT BP-80 LOT - 7423423. RAW MATERIAL FOR TITANIUM RECEIVED FROM SUPPLIER METALWORK PMD, INC. CERTIFICATE OF ANALYSIS AND RAW MATERIAL RECEIVING/ PUTAWAY CHECKLIST RECEIVED FROM METALWORK PMD, INC. MEET SPECIFICATION. INSPECTION SHEET FOR TFNA ASSEMBLY AND INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL MET INSPECTION ACCEPTANCE CRITERIA. NO NON-CONFORMANCE REPORTS (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. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING., A PRODUCT INVESTIGATION WAS PERFORMED. THE RETURNED PART IS INCLUDED IN THE TROCHANTERIC FIXATION NAIL- ADVANCED (TFN-A) SYSTEM AND USED FOR INTRAMEDULLARY FIXATION OF PROXIMAL FEMORAL FRACTURES. THE RETURNED TFNA NAIL WAS RECEIVED UNABLE TO BE DISASSEMBLED FROM THE CONNECTING SCREW (03.037.010) AND INSERTION HANDLE (03.037.011). THE REASON FOR THIS IS MOST LIKELY DUE TO THE CRACK ON THE CONNECTING SCREW WHICH MAY HAVE PREVENTED THE SCREW FROM LOOSENING AND RELEASING ALL PARTS INVOLVED IN THE COMPLAINT. THE COMPLAINT COULD NOT BE REPLICATED AS THE DEVICES ARE ALREADY JAMMED TOGETHER. THE BALANCE OF THE NAIL IS IN FAIR CONDITION, WITH SIGNS OF BEING INSERTED AND REMOVED. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH CURRENT AND FROM THE TIME OF MANUFACTURE). NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. DIMENSIONAL ANALYSIS WAS NOT PERFORMED AS THE COMPLAINT CONDITION WAS VISUALLY CONFIRMED AND RELEVANT FEATURES COULD NOT BE MEASURED AS SCREW IS SEIZED BETWEEN THE HANDLE AND NAIL PREVENTING MEANINGFUL MEASUREMENTS TO BE TAKEN. A ROOT CAUSE COULD NOT BE DETERMINED, AS THE CIRCUMSTANCES LEADING TO THE COMPLAINT ARE UNKNOWN. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE 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. DATE REC¿D BY MFR : DATE WAS INADVERTENTLY OMITTED ON THE PREVIOUS FOLLOW-UP MEDWATCH REPORT MWR-(B)(4). THE DATE SHOULD HAVE BEEN APRIL 18, 2018. 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. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DATE RETURNED TO MANUFACTURER. (B)(6). ADDITIONAL 510K: K160167. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW: MANUFACTURING LOCATION: (B)(6). MANUFACTURING DATE: 11-NOV-2015. EXPIRATION DATE: 30-NOV-2025. PART #: 04.037.013S (EU ITEM NO.) LOT#: 9938400 (STERILE) - 10MM/125 DEG TI CANN TFNA 200MM - STERILE. QUANTITY 5. COMPONENT PARTS REVIEWED: PART 04.037.912.2 - LOCK PRONG, 125 DEGREE, TFNA. BP-55 LOT - 9610722 (3), 9610737 (2). PART 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - 7921046. PART 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT - 9903050. 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. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    IT WAS REPORTED THAT ON (B)(6) 2018, THE FOLLOWING IMPLANT WAS USED IN THE OPERATION FOR FEMORAL TROCHANTER FRACTURE. PROXIMAL FEMORAL NAILING SYSTEM (TFNA FEM NAIL Ø10 125 ° L200 TIMO15 PART NUMBER: 04.037.013S, LOT # 9938400). DURING THE OPERATION, THE SURGEON CONFIRMED THAT THE FOLLOWING EVENT OCCURRED DURING HIS ROUTINE PROCEDURES. THE CHOSEN NAIL WAS TOO SMALL IN DIAMETER NAIL, WHICH WAS INTRODUCED. TO REPLACE THIS NAIL WITH ANOTHER NAIL, THE BLADE AND THEN THE NAIL WAS PULLED OUT. THE CONNECTING SCREW COULD NOT BE REMOVED FROM THE NAIL. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE PARTS EVEN WITH A DRIVER, BUT IT WAS NOT SUCCESSFUL. BY SWITCHING FROM TFNA TO PFNA, THE OPERATION WAS FINALLY COMPLETED SUCCESSFULLY. THE OPERATION WAS DELAYED BY 40 MINUTES AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THIS COMPLAINT INVOLVES THREE PART. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128446 10MM/125 DEG TI CANN TFNA 200MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 9938400 07611819649477

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention