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	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information the anchor pulled out during suture placement check.

• 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: 18320550
• Report Number: 2125050-2023-01575
• Device Sequence Number: 17981619
• 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): 12/13/2023

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 Catalogue Number: 520340
• 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: 12/13/2023
• 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