MAUDE Adverse Event Report: CONMED CORPORATION 3.5MM POPLOK SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	CKP-3501
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event of "rep implanted an expired anchor" is inconclusive.The device will not be returned for evaluation and no photographic evidence was provided; therefore, root cause cannot be identified.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 one complaints, regarding one 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).Per the instructions for use, the user is advised the following: do not use beyond the expiration date listed on the label.The performance, safety and/ or sterility of the device cannot be assured beyond the expiration date.The poplok knotless suture anchor should only be used if the original packaging and labeling are intact.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales manager reported on behalf of the customer that the ckp-3501 device was being used during an unknown procedure on approximately (b)(6) 2021 when it was reported that "i had a rep implant an expired anchor yesterday.The expiration said "2021-04-17"." there was no report of patient impact.A good faith attempt was made to obtain further information, but to date no response has been received.This report is being raised on the basis of injury due to implanting an expired device in the patient.
Event or Problem Description
Update: received additional information on2jun21.The device package was inspected prior to implanting, but the sales representative did not realize the expiration date had passed a few days before.In the dark operating room, the date was misread.The implant had expired the week before, but was read as expiring in one week.The nurse opened the device package to the scrub technician.The nurse and the scrub technician did not verify the expiration date.There was no prophylactic treatment given to the patient and the doctor plans on leaving the device in the patient.

• Brand Name: 3.5MM 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: 11875842
• Report Number: 1017294-2021-00264
• Device Sequence Number: 1009229
• Product Code: MBI
• UDI-Device Identifier: 20845854013714
• UDI-Public: (01)20845854013714(17)210417(30)1(10)1013627
• Combination Product (Y/N): N
• PMA/510(K) Number: K091549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 04/17/2021
• Device Model Number: CKP-3501
• Device Catalogue Number: CKP-3501
• Device Lot Number: 1013627
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other