BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR

    MDR report key: 4863491 · Received June 23, 2015

    Report

    Report Number
    3003875359-2015-10311
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HSB
    PMA / PMN Number
    PK092646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UNK PATIENT INFO. ADDITIONAL PRODUCT CODE: HWC. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DHR REVIEW ¿ MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 17 AUGUST 2010. NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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

    PRODUCT INVESTIGATION SUMMARY: ONE TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR (PART 357.428 / LOT 3487528) WAS RECEIVED WITH THE COMPLAINT CATEGORY OF ¿MALFORMED: BENT/DISTORTED/WARPED.¿ THE COMPLAINT CONDITION IS CONFIRMED AS THE DISTAL TANGS ARE BENT. THE RETURNED CONDITION IS CONSISTENT WITH THE RESULT FROM A HIGH TORQUE LOAD WITH THE INSERTER/EXTRACTOR NOT COMPLETELY SEATED ON THE 11.0MM SCREW. ALTHOUGH THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED, IT IS MOST PROBABLE THAT THE COMPLAINT CONDITION IS A RESULT OF THE METHOD OF USE OVER THE DEVICES 5 YEAR LIFESPAN. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE RETURNED INSERTER/EXTRACTOR. THE DEVICE WAS FOUND TO HAVE BEEN MANUFACTURED IN AUGUST, 2010. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DHR SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. FURTHER EVALUATION SHOWS THAT THIS DEVICE IS USED WHEN THE 11.0MM SCREW OPTION IS THE DESIRED HEAD ELEMENT WITH A TITANIUM TROCHANTERIC FIXATION NAIL (TFN). THIS DEVICE SEATS INTO THE 11.0MM SCREW FOR INSERTION AND EXTRACTION. INFORMATION IS PROVIDED PER THE TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM - SCREW OPTION TECHNIQUE GUIDE. THE RETURNED INSERTER/EXTRACTOR WAS RECEIVED WITH THE DISTAL TANGS SLIGHTLY SPLAYED OUTWARD. ONE DISTAL CORNER OF ONE TANG IS ALSO DENTED. THE BALANCE OF THE DEVICE SHOWS SURFACE SCRATCHES, BUT IS IN OTHERWISE GOOD CONDITION. THUS, THE COMPLIANT CONDITION IS CONFIRMED, BUT CANNOT BE REPLICATED SINCE THE DEVICE IS ALREADY BENT. A REVIEW OF THE CURRENT/MANUFACTURED REVISION FOR THE TOP LEVEL DRAWING AND THE CANNULATED SHAFT COMPONENT DRAWING WAS PERFORMED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE RETURNED CONDITION IS CONSISTENT WITH THE RESULT FROM A HIGH TORQUE LOAD WITH THE INSERTER/EXTRACTOR NOT COMPLETELY SEATED WITH THE 11.0MM SCREW. PER THE TECHNIQUE GUIDE, THERE ARE ARROWS TO SHOW THAT THE FLATS ON THE INSERTER/EXTRACTOR SHOULD ALIGN WITH THE FLATS ON THE IMPLANT. THEN THE COUPLING SCREW SHOULD BE COMPLETELY THREADED, THUS, FULLY SECURING THE SCREW. WHEN PROPERLY ASSEMBLED, THE TANGS WOULD NOT BE EXPECTED TO EXPERIENCE A TORSIONAL LOAD AS THE TORQUE IS TRANSFERRED THOUGH THE HEX CONNECTION BETWEEN THE INSERTER AND SCREW. WHEN FUNCTIONALLY TESTED WITH A KNOWN GOOD 11.0MM SCREW AND COUPLING SCREW, THE DEVICE ASSEMBLED AS INTENDED. SINCE THE SPECIFIC CIRCUMSTANCES AT THE TIME OF THE DAMAGE ARE UNKNOWN, THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED; HOWEVER, IT IS MOST PROBABLE THAT THE COMPLAINT CONDITION IS A RESULT OF THE METHOD OF USE OVER THE DEVICES 5 YEAR LIFESPAN. DEVICE 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

    DURING A REPAIR OF A LEFT HIP FRACTURE, THE TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR SLIPPED OVER THE LAG SCREW AS THE TIP OF THE DEVICE WAS SLIGHTLY BENT; IT ROLLED A LITTLE. THE REPORTER WAS ABLE TO SEE THE SLIGHT BEND UNDER ALREADY PLANNED FLUOROSCOPY. AS THE IMPLANTS WERE ALREADY PERFECTLY ALIGNED THE SURGEON WAS ABLE TO REALIGN THE DEVICE, INSERTING THE LAG SCREW EASILY USING THE DEVICE WITH NO SURGICAL DELAYS OR HARM TO THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO ADDITIONAL SURGICAL INTERVENTION AND THE PATIENT OUTCOME WAS REPORTED AS "FINE." THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405302 TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES HAGENDORF 3487528

    Patients

    Seq Age Sex Outcome Treatment
    1