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

Catalog Number 520350

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, this device required explantation due to released anchors.The anchors from this device released.The anchors were loaded and deployed to the patient.When testing the anchors, they easily released from the tissue.Another manufacturer's device was used.No other adverse patient effects were reported.

Manufacturer Narrative

Examination revealed deformed anchor just distal of the eyelet with cannula gouge marks associated with incorrect anchor loading.At deployment, mis-aligned anchor deflects from fibrous tissue/ bone causing concentrated stress near cannula end resulting in deformed anchor.A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

Event Description

According to available information, this device required explantation due to released anchors.The anchors from this device released.The anchors were loaded and deployed to the patient.When testing the anchors, they easily released from the tissue.Another manufacturer's device was used.No other adverse patient effects were reported.

• Brand Name: SAFFRON ANCHOR
• 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 (Section G): MINNEAPOLIS; 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: 17774513
• MDR Text Key: 323753410
• Report Number: 2125050-2023-01129
• Device Sequence Number: 1
• Product Code: PBQ
• 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,Followup
• Report Date: 01/03/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 520350
• Device Lot Number: 8742960_5203501400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR