MAUDE Adverse Event Report: CONMED CORPORATION 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 Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
Type of Reportable Event	Serious Injury
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 customer reported that ckp-4500 device was using during a rotator cuff repair on (b)(6) 2019.One anchor was implanted and found to be broken in place upon removal of the inserter.The second anchor was found to be broken in the inserter.The implanted anchor had fragmented and the surgeon chose to leave the fragment in the patient.It is unknown if the fragment was in the hole or loose upon review, the reporter did not advise to this extent.There was no injury to the patient or user reported.There was also no report of medical intervention or hospitalization for this event.The procedure was reported to have been completed successfully.This report is being raised on the basis of injury due to fragment's unknown location.
Additional Manufacturer Narrative
Customer complaint of when the inserters were removed it revealed that the implants had broken was not confirmed, due to the broken implant was not returned for evaluation.Customer returned only one used device, item ckp-4500.Device trigger was not pressed in and no issues were found with the driver assembly.The threads in the driver were not damaged.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: precautions: -ensure proper selection of bone punch according to anchor size selection -avoid lateral loading while inserting the poplok knotless suture anchor -maintain proper alignment during insertion of the anchor and disengagement of the driver -proper selection and placement of the implant are important considerations in the successful utilization of this device this issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 4.5MM POPLOK SUTURE ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 8900639
• Report Number: 1017294-2019-00105
• Device Sequence Number: 253992
• Product Code: MBI
• UDI-Device Identifier: 10845854014103
• UDI-Public: (01)10845854014103(17)240526(30)1(10)1026322
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2024
• Device Catalogue Number: CKP-4500
• Device Lot Number: 1026322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other