MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

Two introducers were received for evaluation.Examination revealed the tip of the right introducer to be detached and not returned.Blood residue was noted on both introducers, indicating contact with the patient.No functional abnormalities were noted with the left introducer.Based on the information received, the physician struggled with inserting the introducer into the appropriate path which resulted in the tip of the introducer being slightly bent.This bending most likely occurred as the introducer tip may have been pushing against bone with excess force.The attempt by the tech to adjust the bent introducer tip resulted in the breakage of the tip from the introducer.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 the available information, the physician loaded the dynamic anchor into the trocar and proceeded with attempting to place the sling into the patient's left side.During this process, she struggled with insertion of the trocar into the appropriate path, and when she pulled out the trocar to try again, the tip of the trocar was slightly bent.When the tech adjusted the trocar tip with his instrument, the trocar tip broke off.Another sling was opened and placed with no problem.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12584619
• MDR Text Key: 274995544
• Report Number: 2125050-2021-01462
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2021

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: Lay User/Patient
• Device Expiration Date: 10/29/2023
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 7535834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 46 YR