BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIUM CABLE PASSER

    MDR report key: 7202062 · Received January 17, 2018

    Report

    Report Number
    1719045-2018-10004
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Report Date
    November 29, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    UDI-DI
    07611819719743
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT. DATE OF EVENT: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW, PART NUMBER: 391.105, SYNTHES LOT NUMBER: P063554, SUPPLIER LOT NUMBER: P063554, RELEASE TO WAREHOUSE DATE: 07-JAN-2010, SUPPLIER: (B)(6). REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCTS, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NCRS WERE GENERATED DURING PRODUCTION. AS THE COMPLAINT POINTS TOWARDS THE BROWN RESIDUES NO MEASUREMENTS, NO HARDENING AND NO FURTHER TESTS WERE PROVIDED. AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: PER THE INVESTIGATION WE DID REVIEW: ALL PARTS THAT WERE RETURNED FOR EVALUATION IN STERILIZATION POUCHES AND HAVE BROWN RESIDUES EVIDENT INSIDE THE POUCH. 1X 391.105 / P063554 (CABLE PASSER, MEDIUM). THE PROVIDED VISUAL INSPECTION HAS SHOWN THAT SIGNS OF BROWN RESIDUES COULD BE FOUND INSIDE THE POUCH. CONCLUSION: NO MANUFACTURING RELATED DEVIATION COULD BE FOUND. AS POSSIBLE ROOT CAUSE WE DO STRONG ASSUME THAT THE PROVIDED WASHING AND DECONTAMINATION CYCLES MIGHT HAVE NOT BEEN REPEATED OFTEN ENOUGH IN ORDER GETTING CLEAN INSTRUMENTS. WE LIKE TO REFER ON TO THE DOCUMENT CANEVASIT/PHENOLIC HANDLES ATTACHED. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: WHEN THE REPORTED CAB-1 (THE NAME OF THE SURGICAL TOOL SET ASSORTED IN (B)(6)) WAS ABOUT BEING WASHED POSTOPERATIVELY, IT WAS FOUND THAT SOME BROWN-COLORED LIQUID WAS LEAKING FROM THE PASSER HANDLES. IT WAS UNCERTAIN WHICH PASSER(S) HAD CAUSED THE ISSUE. THE DEVICES IN QUESTION WERE NOT USED FOR THE PATIENT. THIS COMPLAINT INVOLVES 6 PARTS. THIS REPORT IS 4 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43870 MEDIUM CABLE PASSER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT P063554 07611819719743

    Patients

    Seq Age Sex Outcome Treatment
    1