BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 4726202 · Received April 24, 2015

    Report

    Report Number
    3003787298-2015-10021
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Report Date
    April 10, 2015
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PRODUCT INVESTIGATION EVALUATION: ONE OF THE FOLLOWING WAS RECEIVED: LOCKING BOLT MEASURING DEVICE FOR 153MM SLEEVE, TFN (PART 360.255 / LOT 7892062 / MFG. DATE: JANUARY 2015) THE RETURNED DEVICE SHOWS EVIDENCE OF REGULAR USE DURING ITS LIFESPAN. THERE ARE COSMETIC SCRATCHES ON THE OUTSIDE BODY AND THE BALL BEARING ON THE INTERNAL SLIDER IS MISSING. THE DISTAL HOOKED TIP OF THE DEVICE IS UNDAMAGED. IT IS UNKNOWN WHAT CAUSED 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. THE ASSOCIATED DRAWING FOR THE DEVICE(S) WAS REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RETURNED INSTRUMENT(S) ARE USED TO MEASURE SCREW LENGTH DURING FEMORAL NAIL IMPLANTATIONS AND PROPER USE AND MAINTENANCE ARE ADDRESSED IN TECHNIQUE GUIDES. THE CAUSE OF THE COMPLAINT CONDITION COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SUBJECT DEVICE RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE IS 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: EVENT DATE: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: MANUFACTURE DATE: JANUARY 19, 2015. THE DEVICE HISTORY RECORD REVIEW WAS REVIEWED AND NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT SPRING BALL POPPED OUT OF THE DEPTH GAUGE DURING A TROCHANTERIC FIXATION NAIL (TFN) SYSTEM PROCEDURE. THE SLEEVE KEPT SLIDING FROM THE DEPTH GAUGE CORE. THERE WAS AN UNKNOWN SURGICAL DELAY IN GETTING THE SECOND DEPTH GAUGE FROM THE SECOND SET. THE PATIENT STATUS/OUTCOME IS UNKNOWN. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272846 LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS GAUGE, DEPTH HTJ SYNTHES JENNERSVILLE 7892062

    Patients

    Seq Age Sex Outcome Treatment
    1