BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3 300X160MM

    MDR report key: 3132161 · Received May 29, 2013

    Report

    Report Number
    0009610622-2013-00287
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: UPON RECEIPT OF THE TARGET DEVICE IT WAS REALIZED THAT THE ITEM HAD EXPERIENCED CRACKS AT THE TRANSITION TO THE METAL NAIL ADAPTER. FURTHER THE CONNECTING RIM (PEEK MATERIAL) AT THE BOTTOM OF THE TARGETING ARM WHERE THE KNOB OR SPEEDLOCK SLEEVE CAN BE MOUNTED WAS PARTLY BROKEN OFF. THE FOUND CRACKS AT THE TARGET DEVICE WERE CLEAR VISIBLE AND SHOULD HAVE BEEN NOTICED DURING CHECKING OF THE INSTRUMENTS WHICH IS REQUIRED BY IFU PRIOR SURGERY. FOR THE CRACKS IN THE TARGET DEVICE EVALUATION REVEALED THAT THE EVENT IS LINKED TO INTERNAL MATERIAL STRESSES ENFORCED BY MULTIPLE STERILIZATION PROCEDURES AND CLEANING CYCLES OVER THE YEARS OF USE CONTRIBUTED BY THE DESIGN OF THE DEVICE. THE BREAKAGE SURFACE AT THE CONNECTING RIM OF THE RECEPTION AND THE BROKEN OFF PIECE SHOW TYPICAL TRACES OF A BRITTLE BREAKAGE LIKE NO PLASTIC DEFORMATION WHICH SUGGESTS THAT SUDDEN FORCE WAS APPLIED (E.G. ACCIDENTALLY DROPPED OR HAMMER-BLOWS UPON RE-POSITIONING OR REMOVAL OF THE NAIL). FURTHERMORE PRE-DAMAGES IN FORMER SURGERIES CANNOT BE EXCLUDED. ALTHOUGH DAMAGED, FUNCTION AND TARGETING ACCURACY OF THE TARGET DEVICE RETURNED WAS BEING FOUND AS INTENDED. THE DEVICE HAD BEEN IN USE FOR APP. 8 YEARS, AND IT HAD BEEN SUBJECT TO PERIODIC STRESS SITUATIONS DUE TO MULTIPLE APPLICATIONS AND STERILIZATION- AND CLEANING CYCLES. AS IT HAD BEEN IN USE FOR THAT LONG TIME BEFORE CRACKS WERE NOTICED WE PRE-SUPPOSE THAT IT HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. APPEARANCE OF THE ITEM AND INSPECTION RECORDS IDENTIFIED THIS PRODUCT AS OLD DESIGN VERSION. MEANWHILE THE PRODUCT HAS BEEN MODIFIED WITH ECN 6053/07 IN TERMS MATERIAL CHANGE IN ORDER TO AVOID CRACKS AND TO IMPROVE STIFFNESS. THE IMPACTS VISIBLE IN THE CFR-MATERIAL AT THE LOWER SIDE OF THE TARGET DEVICE ARE DUE TO ROUGH HANDLING MOST LIKELY CAUSED BY HAMMERING ONTO THE CFR-MATERIAL WHICH IS NOT DEVICE RELATED BUT RATHER RELATED TO INADEQUATE HANDLING AT USER SITE. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING SURGERY, THE SURGEON NOTICED THAT THE CAP THAT LOCKS THE SLEEVE IN PLACE WAS CRACKED. HE SAID THAT BECAUSE THE CAP WAS CRACKED HE WAS HAVING A HARD TIME KEEPING THE TWO PIECE SLEEVE FOR THE LAG SCREW TO TIGHTEN UP WHEN TWISTING THE CAP. THE SURGEON ALSO NOTICED THAT THERE WAS A CRACK ON THE PROXIMAL PORTION OF THE GAMMA TARGETING ARM CLOSE TO WHERE THE NAIL ATTACHES TO THE TARGETING ARM.

    Description of Event or Problem · 1

    DURING SURGERY, THE SURGEON NOTICED THAT THE CAP THAT LOCKS THE SLEEVE IN PLACE WAS CRACKED. HE SAID THAT BECAUSE THE CAP WAS CRACKED HE WAS HAVING A HARD TIME KEEPING THE TWO PIECE SLEEVE FOR THE LAG SCREW TO TIGHTEN UP WHEN TWISTING THE CAP. THE SURGEON ALSO NOTICED THAT THERE WAS A CRACK ON THE PROXIMAL PORTION OF THE GAMMA TARGETING ARM CLOSE TO WHERE THE NAIL ATTACHES TO THE TARGETING ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236852 TARGET DEVICE GAMMA3 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL KP220960

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other