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 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

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, reported complaint: "we had a defective altis.Anchor broke so surgeon removed the altis and implanted a new altis sling.I was able to collect the device and will be mailing it in.Additional info.Per tm on 12/28/20: "when tensioning the sling, the anchor broke.It was the dynamic anchor." the lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Manufacturer Narrative

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.Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.

Event Description

According to the available information the altis sling was to be implanted on (b)(6) 2020 but when the physician was tensioning the sling, the dynamic anchor broke.Another altis sling was used to successfully complete the surgery.An altis sling was received for evaluation.Examination of the returned sling revealed both the static and dynamic sutures were still attached to the mesh.The static anchor was attached, but the tines were bent outward.The tensioner was present on the dynamic suture, but no dynamic anchor.Blood residue was noted on all components received.Based on the information received the dynamic anchor ¿broke¿ while the physician was tensioning the sling after implant.Examination of the returned device confirmed the dynamic anchor was missing from the tensioner.Without additional information quality is unable to determine the reason for the dynamic anchor detaching from the tensioner during tensioning.

• 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: 11175736
• MDR Text Key: 227037715
• Report Number: 2125050-2021-00069
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• 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: 08/05/2021

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: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 7332038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 08/04/2021
• Patient Sequence Number: 1