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

Model Number 5196502400

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

According to the available information, though not verified, the tip of an altis trocar broke while attempting to implant altis.The physician was attempting to place the static anchor on the patient¿s right side.While attempting to place the anchor with some difficulty they removed the trocar to recognize that the tip of the atlis trocar had broke off.They were unable to locate the tip of the trocar.Nevertheless, they were able to remove the anchor and sling, and place a new altis sling.

Manufacturer Narrative

Two introducers were received for evaluation.Examination of both introducers confirmed the tip of the left introducer to be detached.Microscopic examination of the detachment surfaces revealed them to be rough and irregular.No functional abnormalities were noted with the right introducer.Based on the information received and examination of the returned components, it was concluded that the introducer tip may have been inadvertently pushed against bone during implant.This may then have resulted in the tip bending and ultimately separating 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.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11032950
• MDR Text Key: 222410434
• Report Number: 2125050-2020-01301
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

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 Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 7189638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 03/26/2021
• Patient Sequence Number: 1