BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP FOR DHS®/DCS® IMPACTOR (338.28)

    MDR report key: 3063788 · Received April 17, 2013

    Report

    Report Number
    2530088-2013-10435
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    August 11, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HWA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE RETURNED IMPACTOR TIP (338.26) WAS MANUFACTURED IN JULY 2004 AND IS OVER 7 YEARS OLD. BASED ON THE DEEP GOUGES AND MARKS, AS WELL AS THE DEFORMED MATERIAL WHERE THE TIP BROKE, THIS DEVICE HAS BEEN USED EXTENSIVELY OVER THAT TIME AND HAS BEEN MISALIGNED WITH THE PLATE ON NUMEROUS OCCASIONS WHEN BEING IMPACTED. ALSO, THE TECHNIQUE GUIDE STATES TO GENTLY SEAT THE DHS/DCS PLATE WITH THE IMPACTOR BUT BASED ON THE DAMAGE AND BREAKAGE, THE IMPACTOR HAS BEEN STRUCK WITH SIGNIFICANT FORCE AND OFTENTIMES WHILE MISALIGNED WITH THE PLATE. THE COMPLAINT CONDITION FOR THE IMPACTOR TIP (338.26) IS DUE TO THE AGE OF THE DEVICE COUPLED WITH IT BEING MISALIGNED AND STRUCK WITH EXCESSIVE FORCE ON NUMEROUS OCCASIONS. IT IS CONCLUDED THAT THIS COMPLAINT IS INVALID.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PRODUCT DEVELOPMENT EVENT EVALUATION: THE RETURNED IMPACTOR TIP (338.26) WAS MANUFACTURED IN JULY 2004 AND IS OVER 7 YEARS OLD. BASED ON THE DEEP GOUGES AND MARKS, AS WELL AS THE DEFORMED MATERIAL WHERE THE TIP BROKE, THIS DEVICE HAS BEEN USED EXTENSIVELY OVER THAT TIME AND HAS BEEN MISS-ALIGNED WITH THE PLATE ON NUMEROUS OCCASIONS WHEN BEING IMPACTED. ALSO, THE TECHNIQUE GUIDE STATES TO "GENTLY SEAT THE DHS/DCS PLATE WITH THE IMPACTOR" BUT BASED ON THE DAMAGE AND BREAKAGE, THE IMPACTOR HAS BEEN STRUCK WITH SIGNIFICANT FORCE AND OFTENTIMES WHILE MISALIGNED WITH THE PLATE. THERE ARE (B)(4) OTHER COMPLAINTS IN THE 2 YEAR HISTORY AND OVER (B)(4) DISTRIBUTED SINCE THE BEGINNING OF 2010 FOR A RATE OF APPROXIMATELY (B)(4) BASED ON SALES. THIS INSTRUMENT IS USED REPEATEDLY SO THE RATE BASED ON USE IS SIGNIFICANTLY LOWER AND THE CONDITION OF THE RETURNED PART DEMONSTRATES THAT IT HAS BEEN USED EXTENSIVELY. THE RETURNED FORCEPS HOLD WELL WHEN CLAMPED ONTO A SAW-BONE MODEL AND REQUIRE EFFORT TO DISENGAGE. THEY FEEL ''LOOSE'' IN THE UNCLAMPED POSITION WHICH IS THE STATE THEY WOULD HAVE BEEN IN WHEN SEEN AT CENTRAL STERILE AS REPORTED BUT THEY HOLD WELL WHEN CLAMPED. THEREFORE THE PARTS FUNCTION AS INTENDED. THE RETURNED PARTS WERE MANUFACTURED IN JUNE 1999 AND FEBRUARY 2004 AND HAVE BEEN IN USE FOR AN EXTENDED TIME. THERE HAVE BEEN OVER (B)(4) DISTRIBUTED SINCE THE BEGINNING OF 2010 WITH ONLY (B)(4) OTHER COMPLAINTS IN THE 2 YEAR HISTORY RESULTING IN A RATE OF LESS THAN (B)(4) BASED ON SALES. THESE INSTRUMENTS ARE USED REPEATEDLY SO THE RATE BASED ON USAGE IS SIGNIFICANTLY LOWER. THEREFORE THEY DO NOT EXHIBIT THE COMPLAINT CONDITION WHEN IN USE AND THIS COMPLAINT IS THEREFORE INVALID.

    Description of Event or Problem · 1

    IT WAS NOTICED IN CENTRAL STERILE WHEN CLEANING AND ASSEMBLING TRAYS THAT THE END TIP OF AN IMPACTOR IS BROKEN OFF. THE CONSULTANT DOES NOT KNOW WHEN THE PROBLEMS OCCURRED. NO KNOWN PATIENT INVOLVEMENT THAT THIS TIME. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165989 TIP FOR DHS®/DCS® IMPACTOR (338.28) HWA SYNTHES BRANDYWINE 4767118

    Patients

    Seq Age Sex Outcome Treatment
    1