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

Catalog Number 520340

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

Search for complaint trend against lot number.Search for associated nc and capas against lot number.

Event 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
• Type of Device: 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
• MDR Text Key: 330613876
• Report Number: 2125050-2023-01604
• Device Sequence Number: 1
• Product Code: PBQ
• UDI-Device Identifier: 05708932757423
• UDI-Public: 05708932757423
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 520340
• Device Lot Number: 8814151_5203401400
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1