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

Catalog Number	CKP-4500
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem 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 procedure and ¿when inserting the implant into the hole, it fragments.¿.There was no impact or injury to the patient.The procedure was completed with an alternate same device and there was a 5 minute delay to the procedure.Further assessment found, ¿no fragments remained at the surgical site¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event is confirmed.Visual examination of the returned used device, item ckp-4500, found anchor implant broken and still attached to the shaft, the shaft driver damage (bent), due to excessive force, device trigger was not pressed in.Implant was returned broken.Visual evaluation was performed.Excessive twisting forces may have attributed to this failure.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.Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the implant are important considerations in the successful utilization of this device.Surgeon much choose proper implant size based on specific procedure and patient history.Proper orientation and alignment of instruments is important during implantation of the poplok knotless suture anchor to minimize possible breakage of the anchor.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem 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 procedure and "when inserting the implant into the hole, it fragments".There was no impact or injury to the patient.The procedure was completed with an alternate same device and there was a 5 minute delay to the procedure.Further assessment found, "no fragments remained at the surgical site".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 4.5MM POPLOK SUTURE ANCHOR
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13496858
• Report Number: 1017294-2022-00020
• Device Sequence Number: 3867609
• Product Code: MBI
• UDI-Device Identifier: 10845854014103
• UDI-Public: (01)10845854014103(17)260916(10)1194498
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K091549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2026
• Device Catalogue Number: CKP-4500
• Device Lot Number: 1194498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic