MAUDE Adverse Event Report: CONMED LARGO 4.5MM POPLOK SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number CKP-4500

Device Problem Material Fragmentation (1261)

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

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the (b)(6), 4.5mm poplok suture anchor, was being during a rotator cuff repair on 24nov21 when it was reported, ¿anchor broke and did not fully deploy.¿ there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the device had broken in the surgical site and was removed using graspers.The procedure was completed as plan with a possible 20-30 minute delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the ckp-4500, 4.5mm poplok suture anchor, was being during a rotator cuff repair on (b)(6) 2021 when it was reported, ¿anchor broke and did not fully deploy.¿ there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the device had broken in the surgical site and was removed using graspers.The procedure was completed as plan with a possible 20-30 minute delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.There are two complaints for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 15 complaints, regarding 16 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, (b)(4).Per the instructions for use, the user is advised to avoid lateral loading while inserting the poplok knotless suture anchor.Maintain proper alignment during insertion of the anchor and disengagement of the driver.Proper orientation and alignment of instruments is important during implantation of the poplok knotless suture anchor to minimize possible breakage of the anchor.Breakage of the poplok knotless suture anchor is possible if: a) the bone punch is not inserted to the proper depth; b) the poplok knotless suture anchor is not properly aligned with the pilot hole; c) the poplok knotless suture anchor inserter is used for prying.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the ckp-4500, 4.5mm poplok suture anchor, was being during a rotator cuff repair on (b)(6) 2021 when it was reported, ¿anchor broke and did not fully deploy.¿ there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the device had broken in the surgical site and was removed using graspers.The procedure was completed as plan with a possible 20-30 minute delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 4.5MM POPLOK SUTURE ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 13042615
• MDR Text Key: 285165641
• Report Number: 1017294-2021-00373
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

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 Catalogue Number: CKP-4500
• Device Lot Number: 1195976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Ethnicity: Non Hispanic