MAUDE Adverse Event Report: COLOPLAST A/S ALTIS KIT; SURGICAL MESH

Model Number 5196502400

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/10/2017

Event Type  Injury  

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.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, tip broke off trocar.Event is reportable malfunction.On 12/18/2017 additional information from sales representative: introducer broke on one side while inserting.Had to open second sling.Spoke with the operating room director who stated they were not able to retrieve the tip from the patient.Procedure delayed 5 minutes.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device: one altis mesh was received for evaluation.Examination of the returned device revealed the static anchor tines were bent.The sutures, joints and weld were intact for both static and dynamic anchors.The tensioning collar of the dynamic anchor assembly was intact; however, the dynamic anchor was missing.The information received indicated that the tip broke of the trocar during insertion and remains in the patient.The information received and the observations are consistent with the tip of the trocar contacting the ischiopubic ramus during implantation of the dynamic anchor.The instructions for use instructs users to keep the introducer against the patient's body and parallel with the ipsilateral ischiopubic ramus when advancing the anchor through the obturator membrane.If the introducer is not parallel with the ramus, the tip of the introducer may contact the bone and cause breakage of the tip of the introducer.Therefore, quality concludes that the root cause of the event is user error due to the introducer not being held parallel to the ramus during implantation of the dynamic anchor.This complaint was forwarded to the contract manufacturer (cm) for review.The cm reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, and because the device is not available for evaluation, no further corrective action is required at this time.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, MN 55411 ; 6123024983
• MDR Report Key: 7131137
• MDR Text Key: 95320474
• Report Number: 2125050-2017-00630
• 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
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 5196502400
• Device Catalogue Number: 5196502400
• Device Lot Number: 5503754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other