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

Catalog Number	CKP-4502
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2022
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.Device not yet received.
Event or Problem Description
The distributor reported on behalf of their customer that the ckp-4502, 4.5mm poplok suture anchor, was being used during a rotator cuff repair procedure on (b)(6) 2022 when it was reported, ¿the anchors were broken during the surgery.¿ further assessment questioning found ¿when the safety lock was deactivated and the lever was squeezed, the wings were broken.¿ the device did fragment and was retrieved using an ¿instrument from the hospital¿.The procedure was completed with another anchor and there was no delay reported during the procedure.There was no report of injury, medical intervention, or hospitalization for the patient.The current status of the patient is ¿good, no complications¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device has not been returned for evaluation to date and no photographic evidence was provided therefore the reported event 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.This is the only complaint 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 10 complaints, regarding 10 devices, for this device family and failure mode.(b)(4).Per the instructions for use, the user is advised the following: 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 must choose proper implant size based on specific procedure and patient history.Avoid lateral loading while inserting the poplok knotless suture anchor.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 their customer that the ckp-4502, 4.5mm poplok suture anchor, was being used during a rotator cuff repair procedure on (b)(6) 2022 when it was reported, ¿the anchors were broken during the surgery.¿ further assessment questioning found ¿when the safety lock was deactivated and the lever was squeezed, the wings were broken.¿ the device did fragment and was retrieved using an ¿instrument from the hospital¿.The procedure was completed with another anchor and there was no delay reported during the procedure.There was no report of injury, medical intervention, or hospitalization for the patient.The current status of the patient is ¿good, no complications¿.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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 15562983
• Report Number: 1017294-2022-00097
• Device Sequence Number: 6575546
• Product Code: MBI
• UDI-Device Identifier: 10845854014127
• UDI-Public: (01)10845854014127(17)230729(10)1183776
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K091549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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: 07/29/2023
• Device Catalogue Number: CKP-4502
• Device Lot Number: 1183776
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic