BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTRESS/COMPRESSION NUT FOR 357.369

    MDR report key: 6041310 · Received October 19, 2016

    Report

    Report Number
    2520274-2016-14979
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 29, 2016
    Report Date
    September 29, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HST
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICES. THE RETURNED INSTRUMENTS WERE EXAMINED AND THE CONSTRUCT WAS ABLE TO BE TO BE ASSEMBLED AND FOUND TO TARGET THE NAIL¿S PROXIMAL LOCKING AS INTENDED. UPON FURTHER EXAMINATION THE FOLLOWING DEFICIENCIES WERE IDENTIFIED WITH THE RETURNED DEVICES: NAIL: BROKEN LOCKING MECHANISM, AIMING ARM: SIGNIFICANT WEAR RESULTING IN A LOOSE CONNECTION WITH THE BUTTRESS/COMPRESSION NUT/GUIDE SLEEVE ASSEMBLY, 11.0MM/3.2MM WIRE GUIDE AND 3.2MM TROCAR: MISSING YELLOW EPOXY COLOR COATING, HELICAL BLADE INSERTER: BROKEN LOCATING PIN FOR ALIGNMENT INDICATOR. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. THE REMAINDER OF THE DEVICES (LISTED BELOW) SHOWED NO DEFECTS OF DEFICIENCIES WHICH MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT CONDITION, AS SUCH THE COMPLAINTS OF LOOSE RELEVANT TO THE FOLLOWING DEVICES ARE UNCONFIRMED: HELICAL BLADE (456.305 LOT H088969), BLADE GUIDE SLEEVE (357.369 LOT 5009622), BUTTRESS/COMPRESSION NUT (357.371 LOT 4941439), HELICAL BLADE COUPLING SCREW (357.377 LOT IS10280), CANNULATED CONNECTING SCREW (357.397 LOT 6649035), INSERTION HANDLE (357.411 LOT 4762525), NUT FOR SHAFT (360.244.2 LOT UNKNOWN) RELEVANT DRAWINGS FOR THE RETURNED DEVICES WERE REVIEWED (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE). THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED DEVICES' LOT NUMBERS AND NO RELEVANT MATERIAL REVIEW RECORDS (MRRS), NON-CONFORMANCE REPORTS (NCRS) OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBERS WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITIONS. 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

    (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. PART 357.371, SYNTHES LOT 4941439: RELEASE TO WAREHOUSE DATE: MAY 13, 2005. NO NON-CONFORMANCE REPORTS 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. 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

    IT WAS REPORTED THAT DURING THE INITIAL TROCHANTERIC FIXATION NAIL (TFN) SURGERY PERFORMED ON (B)(6) 2016 TO TREAT PROXIMAL FEMUR FRACTURE, THE HELICAL BLADE GOT STUCK INSIDE THE TROCHANTERIC FIXATION NAIL. DURING THE PROCEDURE, THE SURGEON ASSEMBLED THE AIMING ARM, BLADE GUIDE SLEEVE, COMPRESSION NUT, HELICAL BLADE INSERTER, HELICAL BLADE COUPLING SCREW, GUIDE WIRE, TROCAR, CANNULATED CONNECTING SCREW AND INSERTION HANDLE AS PER INSTRUCTIONS TO IMPLANT HELICAL BLADE AND NAIL. WHEN THE SURGEON WAS INSERTING THE HELICAL BLADE IT WOULDN'T GO THROUGH THE NAIL. THE SURGEON KEPT HAMMERING BUT THE HELICAL BLADE STILL WOULDN'T GO THROUGH AND GOT STUCK INSIDE THE NAIL. THE SURGEON BELIEVES THE INSTRUMENTS WHICH WERE USED TO IMPLANT THE NAIL AND HELICAL BLADE MAY BE WORN OUT AND LOOSE; THEY ARE NOT MAINTAINING THEIR INTEGRITY IN TERMS OF TIGHTNESS AND BECAUSE OF THAT THERE MIGHT BE MISALIGNMENT. AT THIS POINT THE SURGEON DECIDED TO TAKE OUT THE NAIL AND BLADE. WHEN SURGEON WAS TAKING OUT THE NAIL THE LOCKING MECHANISM OF THE NAIL BROKE INSIDE THE NAIL. ALL OF THE BROKEN PIECES WERE RETRIEVED. THE SURGEON THEN REQUESTED A DIFFERENT INSTRUMENT SET AND IMPLANTED A NEW 95MM HELICAL BLADE AND A NEW TFN NAIL. REPORTEDLY THERE WAS BETWEEN A SURGICAL DELAY OF FORTY-FIVE (45) TO SIXTY (60) MINUTES DUE TO THE REPORTED ISSUES. THE PATIENT'S SURGERY WAS ALSO COMPLICATED BECAUSE OF HER PREEXISTING PULMONARY EMBOLISM TREATED WITH BLOOD THINNERS AND PATIENTREFUSAL OF BLOOD TRANSFUSION PRIOR TO SURGERY BECAUSE OF HER RELIGION. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO OTHER MEDICAL INTERVENTION. IT TOOK A WHILE TO STABILIZE PATIENT AFTER THE SURGERY AS PATIENT LOST EXTRA BLOOD DUE TO HER PREEXISTING CONDITION OF PULMONARY EMBOLISM AND DUE TO SURGICAL DELAY CAUSED BY REPORTED ISSUES. THIS IS REPORT 5 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693274 BUTTRESS/COMPRESSION NUT FOR 357.369 TRACTION, APPARATUS, NON-POWERED HST SYNTHES BRANDYWINE 4941439

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR