MAUDE Adverse Event Report: CONMED LARGO LINVATEC SRS POPLOK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	CKP-4500
Medical Device Problem Codes	Material Fragmentation (1261); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The distributor reported that ckp-4500, poplok suture anchor, 4.5 mm, was being used on (b)(6) 2024 during an unknown procedure when it was reported ¿it hits wide, and the tip is disassembled, and the screw is broken.¿.Further assessment questions were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.The procedure was completed with the use of the same alternate device and there was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported injury due to the possibility of the patient retaining a foreign body.
Event or Problem Description
The distributor reported that ckp-4500, poplok suture anchor, 4.5 mm, was being used on (b)(6)2024 during an unknown procedure when it was reported ¿it hits wide, and the tip is disassembled, and the screw is broken.¿.Further assessment questions were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.The procedure was completed with the use of the same alternate device and there was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported injury due to the possibility of the patient retaining a foreign body.
Additional Manufacturer Narrative
Reported event of ¿tip is disassembled, and the screw is broken¿ is confirmed.The device has not been returned to date, but photographic evidence has been provided.If the device is returned, at a later date, the investigation may be updated and reanalyzed.Root cause cannot be determined, however, based upon ifu; a possible cause of this event could be excessive lateral loading.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.A two-year lot history review shows a total of (b)(4) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) 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, the rate of failure would be (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.The risk of poplok knotless suture anchor breakage during implantation is reduced by following the specified instructions for use listed below.Proper selection and placement of the implant are important considerations in the successful utilization of this device.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: the bone punch is not inserted to the proper depth.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
Update: upon further inspection it was confirmed that the screw did not appear to have any loose fragments from the peek anchor component.Further assessment of the photo provided was completed by the engineering team and therefore the reportability decision changed from an adverse event (serious injury) to a product problem (malfunction).The distributor reported that ckp-4500, poplok suture anchor, 4.5 mm, was being used on (b)(6) 2024 during an unknown procedure when it was reported ¿it hits wide, and the tip is disassembled, and the screw is broken.¿.Further assessment questions were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.The procedure was completed with the use of the same alternate device and there was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: further assessment of the photo provided was completed by the engineering team and therefore the reportability decision changed from an adverse event (serious injury) to a product problem (malfunction) reported event of ¿tip is disassembled, and the screw is broken¿ is confirmed.The device has not been returned to date, but photographic evidence has been provided.If the device is returned, at a later date, the investigation may be updated and reanalyzed.Root cause cannot be determined, however, based upon ifu; a possible cause of this event could be excessive lateral loading.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.(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.The risk of poplok knotless suture anchor breakage during implantation is reduced by following the specified instructions for use listed below.Proper selection and placement of the implant are important considerations in the successful utilization of this device.Proper orientation and alignment of instruments is important during implantation of the poplok knotless suture anchor to minimize possible breakage of the anchor.

• Brand Name: LINVATEC SRS POPLOK
• Common Device Name: 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 20852475
• Report Number: 1017294-2024-00142
• Device Sequence Number: 12758543
• Product Code: MBI
• UDI-Device Identifier: 10845854014103
• UDI-Public: (01)10845854014103(17)281021(10)1349674
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K091549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CKP-4500
• Device Lot Number: 1349674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 01/02/2025; 06/06/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/15/2025; 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic