BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLLOW-REAMER-COMPL ANTICLOCKWISE CUTTIN

    MDR report key: 3181725 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03793
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    September 5, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. ACCORDING TO THE INFORMATION ON THE DEVICE REPORT, BROWN-REDDISH DISCOLORATION ON THE LASER MARKED AREAS OF TREPHINE, COMPLETE, CUT COUNTER CLOCKWISE, FOR SCREWS Ø 3.5 AND 4.0, ITEM 309.035, LOT 2759082 WAS FOUND AT THE WAREHOUSE (SYNTHES (B)(4)). THE MACROSCOPIC EXAMINATION OF THE THREE OUT OF THE EIGHT CUTTERS REVEALED SIMILAR DISCOLORATION ON THE LASER MARKED AREAS. ON THE ONE HAND, BROWN-REDDISH DISCOLORATIONS WERE FOUND WHICH PROBABLY HAVE TO DO WITH IRON OXIDE. ON THE OTHER HAND, BLUE DISCOLORATIONS ON THE LASER MARKING WERE DOCUMENTED WHICH COULD HAVE TO DO WITH ANNEALING COLORS WHICH OCCURRED THROUGH THE IMPACT OF HEAT DURING LASER ENGRAVING. THE WIDTH OF THE ENGRAVING COULD POINT TOWARDS A DOUBLE LASER MARKING. THE EXAMINATION BY SEM OF THE DISCOLORED AREAS REVEALED PARTICLES AND SMALL BUBBLES OF ALL THREE TREPHINES. IT IS PROBABLY AN OXIDE FORMATION ON THE HEAT-AFFECTED ZONE OF THE LASER MARKING. FURTHERMORE, IN SOME CASES, SCALE-LIKE PARTICLES WERE FOUND ON THE LASER MARKED AREAS. THESE WERE PROBABLY CAUSED BY THE SLAG (OXIDE-LIKE FORMATION THROUGH HEAT TREATMENT) WHICH AROSE ON THE SURFACE OF THE INSTRUMENT. THE ENERGY DISPERSIVE X-RAY ANALYSIS (EDX) EXAMINED THE DISCOLORED AREAS. THE BROWN-REDDISH PARTICLES AND BUBBLES REVEALED A HIGH CONTENT OF OXYGEN AS WELL AS CARBON, CALCIUM, CHLORINE AND POTASSIUM. IT IS PRESUMABLY IRON OXIDE AND PACKAGING RESIDUES WHICH OCCURRED THROUGH THE RUBBING OF THE INSTRUMENT ON THE PACKAGING,(BAG MADE OF PLASTIC). THE DISCOLORATIONS ON THE MARKED AREAS WERE CAUSED BY A LASER MARKING PROCESS WHICH WAS NOT OPTIMAL. THE SMALL DISTANCE BETWEEN THE INDIVIDUAL CHARACTERS AS WELL AS THE SCALE-LIKE DEPOSITION ON THE SURFACE POINT TOWARDS A LESS-THAN-IDEAL LASER PROCESS. AN ENERGY SETTING OF THE LASER WHICH WAS SLIGHTLY TOO HIGH OR A LESS-THAN-IDEAL FOCUSING OF THE LASER COULD HAVE HAD A BIG IMPACT ON THE SURFACE OF THE MATERIAL AND THUS LED TO AN IRON OXIDE FORMATION. A DOUBLE LASER MARKING OF THE INSTRUMENTS AND/OR AN UNFAVORABLE SETTING OF THE LASER PARAMETERS COULD EXPLAIN THE ANNEALING COLORS AND THE IRON OXIDE FORMATION.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS DISCOLORATION ON THE INSTRUMENT. THIS IS REPORT 2 OF 9 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283263 HOLLOW-REAMER-COMPL ANTICLOCKWISE CUTTIN HTO SYNTHES GMBH 2759082

    Patients

    Seq Age Sex Outcome Treatment
    1