BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1173863 · Received July 4, 2008

    Report

    Report Number
    8010877-2008-00002
    Event Type
    Other
    Date Received
    July 4, 2008
    Manufacturer
    KOSCHER & WUERTZ GMBH
    Product Code
    HTD
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S DESCRIPTION OF THE COMPLAINT: ACCORDING TO THE CUSTOMER'S INFO, THE HINGE PIN CAME OFF DURING SURGERY AND FELL INTO THE ABDOMEN OF THE PT. BOTH THE PIN AND A SMALL PIECE OF METAL WERE SUCCESSFULLY RETRIEVED FROM THE ABDOMEN. FURTHERMORE, THE PT WAS X-RAYED TO ENSURE THAT NO PIECES REMAINED IN THE BODY. NO PT INJURY OCCURRED AS A RESULT OF THAT. AT THE DIST'S REQUEST, WE REVIEWED THE PRODUCTION DOCUMENTS, CARRIED OUT A THOROUGH EXAMINATION ON THE INSTRUMENT AND CONDUCTED A TREND ANALYSIS COVERING THE PAST FIVE YEARS. RESULTS: OF INSTRUMENT PART # 630-100 WITH LOT # 030800, A TOTAL QUANTITY OF 7 INSTRUMENTS WERE MFG IN JANUARY 2000 AND SHIPPED TO DISTRIBUTOR IN 2000. SINCE 1998, A TOTAL OF 92 INSTRUMENTS WITH PART # 630-100 HAVE BEEN SUPPLIED TO THE DISTRIBUTOR. A TREND ANALYSIS CONDUCTED BY US BASED ON A COMPLAINT EVAL DID NOT REVEAL ANY STRIKING FEATURES INDICATING AN ACCUMULATIVE OCCURRENCE OF THIS TYPE OF NONCONFORMANCE. WITHIN THE PAST FIVE YEARS, THERE HAVE BEEN NO COMPLAINTS OR MDR REPORTING OF THE NONCONFORMANCE DESCRIBED. UPON TRACING BACK THE LOT NUMBER IN QUESTION, WE FOUND THAT BOTH THE CORRECT MATERIAL AND COMPONENTS HAD BEEN USED, AND THAT THE INSTRUMENT IS IN CONFORMANCE WITH THE PRODUCT SPECS. AN EXAMINATION OF THE INSTRUMENT REVEALED THE FOLLOWING: THE RIVET WAS TORN OUT OF THE HINGE, AS A RESULT OF WHICH THE RIVET HOLES ON THE HINGES WERE WIDENED. PLEASE REFER TO THE PICTURES ATTACHED. CONCLUSION: THE INSTRUMENT IS IN ACCORDANCE WITH THE SPECS. WE HAVE NO EXPLANATION AS TO WHAT EXACTLY THIS DAMAGE WAS CAUSED BY. THE FACT THAT THE RIVET HOLES ARE WIDENED INDICATES THAT THERE MIGHT HAVE BEEN AN OVERSTRESSING OF THE INSTRUMENT. CORRECTIVE AND PREVENTIVE ACTION: BASED ON OUR EXAMINATION, WE HAVE NO INDICATION WHATSOEVER THAT EITHER THE DESIGN, MATERIAL, OR MFG PROCESS, OR ANY CIRCUMSTANCES WITHIN OUR SPHERE OF INFLUENCE HAVE GIVEN CAUSE FOR ANY CORRECTIVE OR PREVENTIVE ACTION TO BE INITIATED BY US. NO ACTION WILL THEREFORE BE TAKEN BY US. AS REQUESTED, THE INSTRUMENT IN QUESTION WILL BE RETURNED TO YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * HTD KOSCHER & WUERTZ GMBH * 030800

    Patients

    Seq Age Sex Outcome Treatment
    1