MAUDE Adverse Event Report: COLOPLAST A/S SUPRIS RETROPUBIC KIT; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number	51956
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.
Event or Problem Description
According to the available information, the supris sling broke in half when it was being pulled up through the pelvic incisions.It was easily removed from the patient.The surgeon repeated the procedure with another supris sling and the procedure went fine.The patient did not appear harmed in any way.
Event or Problem Description
According to the available information, the supris sling broke in half when it was being pulled up through the pelvic incisions.It was easily removed from the patient.The surgeon repeated the procedure with another supris sling and the procedure went fine.The patient did not appear harmed in any way.
Additional Manufacturer Narrative
A supris sling was returned for evaluation.Examination of the sling revealed that the mesh was torn in two places.Microscopic examination of the detachment surfaces revealed rough and irregular surfaces, indicating excess stress may have been exerted.Blood residue was noted on the mesh.The information received indicated that the supris sling broke in half while being pulled through the pelvic incisions.Quality confirmed the mesh had torn in two different places.As the detachment surfaces of the mesh were rough and irregular, this indicated that excess stress was most likely exerted to result in the separation noted.A review of the device history record 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.The supplier of the mesh completed an investigation, they concluded there was no element to conclude that the product is faulty.

• Brand Name: SUPRIS RETROPUBIC KIT
• Common Device Name: FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• 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: 20135253
• Report Number: 2125050-2024-01361
• Device Sequence Number: 7277648
• Product Code: OTN
• UDI-Device Identifier: 05708932490016
• UDI-Public: 5708932490016
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111233
• 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,Followup
• Report Date (Section B): 11/15/2024

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: 09/30/2025
• Device Catalogue Number: 51956
• Device Lot Number: 7945558_5195622400
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Unknown