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

Catalog Number	520350
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the benefit of analyzing the device, coloplast 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.The additional saffron anchor is captured under a separate report.
Event or Problem Description
According to the available information, upon inserting and deploying the first saffron anchor, the doctor tested the placement of it and it seemed secure.A second anchor was loaded into the saffron device, when the doctor went to place it , it would not deploy from the saffron tool.It seemed stuck in the device and pulled out when the saffron tool was removed from the patient's left side.At that same time, the doctor checked the first anchor placed on the patient's right side, and it came loose.There was a small amount of tissue in the anchor that pulled out.A new saffron tool was ultimately used, and the suture was switched from a zero pds [polydioxanone] to a 2.0 pds to successfully place an anchor into the right and left sacrospinous ligaments.The rest of the procedure was completed without issue.

• Brand Name: SAFFRON ANCHOR
• 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: 20427222
• Report Number: 2125050-2024-01610
• Device Sequence Number: 18049006
• Product Code: PBQ
• UDI-Device Identifier: 05708932757690
• UDI-Public: 05708932757690
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K220420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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: 03/28/2026
• Device Catalogue Number: 520350
• Device Lot Number: 8868311_5203501400
• 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: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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