MAUDE Adverse Event Report: COLOPLAST A/S SAFFRON FIXATION TOOL; SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE

Catalog Number	520340
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Search for complaint trend against lot number.Search for associated nc and capas against lot number.
Event or Problem Description
According to the available information the surgeon complained about hands being too small to reach ssl and misfired multiple times into surrounding tissue.There was tissue in the anchors that pulled out.Tool eventually stopped firing at the same force and unable to penetrate ssl.It was noted there was an anchor retained in the tool.Another saffron was opened, and anchor was placed successfully into ssl on first try.

• Brand Name: SAFFRON FIXATION TOOL
• Common Device Name: SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18336655
• Report Number: 2125050-2023-01604
• Device Sequence Number: 8424576
• Product Code: PBQ
• UDI-Device Identifier: 05708932757423
• UDI-Public: 05708932757423
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2026
• Device Catalogue Number: 520340
• Device Lot Number: 8814151_5203401400
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2023
• Date Device Manufactured: 02/28/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown