BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE L80 TAN

    MDR report key: 7134959 · Received December 20, 2017

    Report

    Report Number
    8030965-2017-50880
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    November 24, 2017
    Report Date
    November 24, 2017
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819652422
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: ARTICLE 04.038.280S / H201009 WAS MANUFACTURED IN US. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 05-OCT-2016. EXPIRATION DATE: 01-SEP-2026. PART #: 04.038.280S, LOT#: H201009 (STERILE) - TFNA HELICAL BLADE 80MM -STERILE, QUANTITY (B)(4). RAW MATERIAL PART NO: 21012 LOT NUMBER BP82 9974142 REVIEWED. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET SPECIFICATION. INSPECTION SHEET FOR IN-PROCESS ACCEPTANCE SHEET AND INSPECTION & FINAL INSPECTION MEET SPECIFICATION. NO 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. ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ NO 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. REVIEWING DHR SHOWS THAT THE AFFECTED LOT WAS RELEASED AFTER COMPLETE FINAL INSPECTION WITH NO DETECTED ISSUES REGARDING MANUFACTURING PROCEDURE. THIS SCREW WAS RELEASED IN FAULTLESS CONDITION. FOR DETAILS, PLEASE SEE APPROPRIATE SECTION DEVICE HISTORY. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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¿S IDENTIFIER AND WEIGHT ARE UNKNOWN. PATIENT'S AGE IS REPORTED AS IN HER 80S. DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER PHONE NUMBER IS NOT PROVIDED FOR REPORTING. (B)(4). 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DEVICES WERE USED IN SURGERY FOR LEFT FEMUR TROCHANTERIC FRACTURE ON (B)(6) 2017. AFTER THE FEMUR FRACTURE REDUCTION, THE SURGEON INSERTED THE 80 MM BLADE DECREASING EXTRA TRACTION. THEN, THE FEMORAL HEAD TURNED LATERALLY AND MEDIALLY. THE SURGEON EXPLANTED THE BLADE, REPOSITIONED THE FRACTURED AREA, AND REINSERTED THE BLADE. HOWEVER, THE FRACTURED AREA WAS SEPARATED FOR 10 MM FURTHER. BECAUSE OF THIS, THE SURGEON REPLACED WITH THE 90 MM BLADE, COMPRESSED AND TIGHTENED THE FRACTURED AREA, AND COMPLETED THE SURGERY WITH A TEN (10) MINUTE SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGEON COMMENTED THAT THE POSSIBLE CAUSE MIGHT HAVE BEEN AN EARLY RELEASE OF TRACTION. THE PATIENT WILL UNDERTAKE CAREFUL REHABILITATION AND EVENTUALLY A NON-WEIGHT-BEARING TREATMENT, TOO. CONCOMITANT DEVICES REPORTED: 9 MM/125 DEGREE TI CANNULATED TFNA 170 MM ¿ STERILE (PART # 04.037.912S, LOT # H358232, QUANTITY 1), 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 32 MM F/IM NAIL-STERILE (PART # 04.005.522S, LOT # L540401, QUANTITY 1), GUIDE WIRE 3.2 L400 (PART # 357.399S, LOT # L321099, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 80 MM STERILE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915605 TFNA HELICAL BLADE L80 TAN ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H201009 07611819652422

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention