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

Catalog Number	CKP-4500
Medical Device Problem Codes	Material Separation (1562); Failure to Eject (4010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of the anchor pulling out with the driver and broken wing is confirmed.A visual evaluation of the returned device was performed per assembly print of the ckp-4500 device.The examination of the device found the anchor detached from the shaft with a broken wing.The evaluation also found both device handles with broken threads and the device trigger was not pressed in.It is suspected that excessive force was used during assembly of the handle assemblies.The manufacturing documents from the device history record (dhr) have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.A dhr review found no abnormalities that would contribute to this issue.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 (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).The instructions for use (ifu) provides the user with information regarding the proper care and use of this device.It is standard medical practice to inspect and/or test all medical equipment prior to use.The ifu also advises the user is of warnings, cautions and techniques including the following: warnings: surgeon must choose proper implant size based on specific procedure and patient history.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 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 or Problem Description
The customer reported an issue with the 4.5mm poplok suture anchor, item # ckp-4500, lot # 971177 that occurred on (b)(6) 2019 during a rotator cuff repair involving a female patient.It was reported that after making a pilot hole using pkl-45m, the surgeon loaded 4 sutures into the loop and placed the tip of anchor until the required depth mark was reached.After pushing the trigger, the anchor was not detached from a driver and it was pulled out with the driver.It was determined that one of wings had broken off inside the patients body.The broken piece was removed using a grasper and it was disposed of at the hospital.There was no report of impact or injury to the patient and no additional surgical intervention was required.The surgery was completed successfully using another ckp-4500 with a 5-minute delay.This report is being raised on the basis of a device malfunction with potential of injury upon reoccurrence.

• 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 4908
• MDR Report Key: 8357688
• Report Number: 1017294-2019-00017
• Device Sequence Number: 13987761
• Product Code: MBI
• UDI-Device Identifier: 10845854014103
• UDI-Public: (01)10845854014103(17)231030(30)1(10)971177
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K091549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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: 10/30/2023
• Device Catalogue Number: CKP-4500
• Device Lot Number: 971177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1