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

Model Number CKP-4500

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 01/21/2022

Event Type  Injury  

Event Description

The distributor reported on behalf of the customer that the device, ckp-4500, 4.5mm poplok suture anchor was being used on (b)(6) 2022 during a cruciate ligament reconstruction and "when inserting the implant into the hole, it fragments.¿ there was no impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.The procedure was completed with an alternate same device.There was a 5 minute delay to the procedure.A good faith effort was attempted to gain further information; however, to date no reply has been received.This report is being raised on the basis of injury due to the lack of information regarding recovery of fragments from the patient.

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.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.

Manufacturer Narrative

Correction: health effect - clinical code section f10 and medical device problem code.Section f10 were changed to health effect - clinical code section h6 and medical device problem code section h6 as they were in the incorrect section.Manufacturer narrative: examination of the returned used device, item ckp-4500, found shaft and anchor broken.Broken anchor still attached to the driver tip.Excessive force used during case.Device trigger was not pressed in.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.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: 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: the bone punch is not inserted to the proper depth; the poplok knotless suture anchor is not properly aligned with the pilot hole; 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 distributor reported on behalf of the customer that the device, ckp-4500, 4.5mm poplok suture anchor was being used on (b)(6) 2022 during a cruciate ligament reconstruction and " when inserting the implant into the hole, it fragments.¿.There was no impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.The procedure was completed with an alternate same device.There was a 5 minute delay to the procedure.A good faith effort was attempted to gain further information; however, to date no reply has been received.This report is being raised on the basis of injury due to the lack of information regarding recovery of fragments from the patient.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 15043560
• MDR Text Key: 296077899
• Report Number: 1017294-2022-00081
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 20845854014100
• UDI-Public: (01)20845854014100(17)260916(10)1194498
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K091549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CKP-4500
• Device Catalogue Number: CKP-4500
• Device Lot Number: 1194498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic