BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFFRON FIXATION TOOL

    MDR report key: 22786959 · Received August 12, 2025

    Report

    Report Number
    2125050-2025-01290
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 28, 2025
    Report Date
    November 17, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    PBQ
    UDI-DI
    05708932757423
    PMA / PMN Number
    K220420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN BELIEVED THE SAFFRON WAS NOT WORKING PROPERLY AND THE PHYSICIAN EXPERIENCED DIFFICULTIES DURING THE PROCEDURE, AS WELL AS REPORTING THAT THE ¿CLICK¿ WAS NOT HEARD DURING SEEDING OF THE ANCHOR IN THE TOOL. WHILE NO FUNCTIONAL ABNORMALITIES WERE NOTED DURING TESTING WITH THE RETURNED COMPONENTS, MICROSCOPIC EXAMINATION OF THE DISTAL TIP REVEALED THAT THE CANNULA APPEARED TO BE ROTATED ROUGHLY 180 DEGREES. FURTHER EXAMINATION OF THE DELIVERY TOOL NOTED THAT THE ENTIRE OUTER SHAFT HAD ALSO ROTATED TO THE SAME DEGREE. IT WAS CONCLUDED THAT THE OUTER SHAFT MOST LIKELY HAD EXCESSIVE FORCE EXERTED UPON IT, RESULTING IN THE SHAFT ROTATING OUT OF ITS INTENDED ORIENTATION. THIS WOULD RESULT IN THE CANNULA APPEARING TO BE ROTATED WITHIN THE SHAFT. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCE'S AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED TO BE ASSOCIATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, QUALITY CANNOT COMMENT ON THE CONDITION OF THE DEVICE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE SURGEON WAS PERFORMING AN ANTERIOR REPAIR WITH AXIS DERMIS GRAFT, ATTACHING IT TO THE SACROSPINOUS LIGAMENT WITH THE SAFFRON FIXATION TOOL USING 2-0 POLYPROPYLENE SUTURE. THE SURGEON IMPLANTED BOTH SUTURES IN THE SACROSPINOUS LIGAMENT; HOWEVER, BOTH THE SURGEON AND THE SCRUB TECH STRUGGLED TO HEAR THE REQUISITE CLICK OF THE ANCHOR BEING SEEDED INTO THE TOOL. THE PHYSICIAN DID NOT FEEL LIKE THE DEVICE WAS WORKING PROPERLY BUT HE PROCEEDED. HE TUGGED ON BOTH SUTURES, AND THEY APPEARED TO BE LODGED WITHIN THE LIGAMENT. WHEN HE WAS TYING THE SUTURES DOWN, THE ANCHOR ON THE PATIENT¿S RIGHT-SIDE LIGAMENT DISLODGED. THE PHYSICIAN REQUESTED ANOTHER SAFFRON TOOL BECAUSE HE DID NOT BELIEVE THE FIRST ONE WAS WORKING PROPERLY. THE CIRCULATOR OPENED A SECOND SAFFRON TOOL, WHICH WAS FROM THE SAME LOT. AGAIN, BOTH THE SCRUB TECH AND THE PHYSICIAN STRUGGLED TO HEAR THE CLICK. HE WAS ABLE TO GET THE ANCHOR IMPLANTED INTO THE SACROSPINOUS LIGAMENT WITH SUCCESS. THERE WAS NO EFFECT TO THE PATIENT.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE SURGEON WAS PERFORMING AN ANTERIOR REPAIR WITH AXIS DERMIS GRAFT, ATTACHING IT TO THE SACROSPINOUS LIGAMENT WITH THE SAFFRON FIXATION TOOL USING 2-0 POLYPROPYLENE SUTURE. THE SURGEON IMPLANTED BOTH SUTURES IN THE SACROSPINOUS LIGAMENT; HOWEVER, BOTH THE SURGEON AND THE SCRUB TECH STRUGGLED TO HEAR THE REQUISITE CLICK OF THE ANCHOR BEING SEEDED INTO THE TOOL. THE PHYSICIAN DID NOT FEEL LIKE THE DEVICE WAS WORKING PROPERLY BUT HE PROCEEDED. HE TUGGED ON BOTH SUTURES, AND THEY APPEARED TO BE LODGED WITHIN THE LIGAMENT. WHEN HE WAS TYING THE SUTURES DOWN, THE ANCHOR ON THE PATIENT¿S RIGHT SIDE LIGAMENT DISLODGED. THE PHYSICIAN REQUESTED ANOTHER SAFFRON TOOL BECAUSE HE DID NOT BELIEVE THE FIRST ONE WAS WORKING PROPERLY. THE CIRCULATOR OPENED A SECOND SAFFRON TOOL, WHICH WAS FROM THE SAME LOT. AGAIN, BOTH THE SCRUB TECH AND THE PHYSICIAN STRUGGLED TO HEAR THE CLICK. HE WAS ABLE TO GET THE ANCHOR IMPLANTED INTO THE SACROSPINOUS LIGAMENT WITH SUCCESS. THERE WAS NO EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378891 SAFFRON FIXATION TOOL SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE PBQ COLOPLAST A/S 9028575_5203401400 05708932757423

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown