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

Model Number 5196502400

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

The lot # 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.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, when the physician implanted the static anchor side of the sling, the metal tip of the introducer broke off and the anchor did not attach to the obturator membrane.When the physician pulled the side of the sling, the anchor came right out with the broken metal tip still attached.The physician said the anchor seemed to go in easily and that he did not hit any bone.A second altis sling was implanted and the patient was not harmed.

Manufacturer Narrative

Two introducers were received for evaluation.Examination revealed the tip of the right introducer to be detached and not returned.No functional abnormalities were noted with the left introducer.Based on the information received when the physician implanted the static anchor the metal tip of the introducer broke off, and the anchor did not attach to the obturator membrane.The physician stated that the static anchor seemed to go in easily and that he did not hit any bone.Damage to the introducer tip is noted when it is pushed against the bone and not around while placing the anchors.As the physician stated he did not hit bone, quality is unable to determine the cause of the detached introducer tip.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: 11274100
• MDR Text Key: 230102317
• Report Number: 2125050-2021-00093
• 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: 09/24/2021

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 Expiration Date: 07/10/2023
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 7320737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 09/11/2021
• Supplement Dates FDA Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1