MAUDE Adverse Event Report: CONMED CORPORATION ANATOMIC ACL DISPOSABLE KIT; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Model Number	8820
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, although multiple attempts have been made to gather additional information, no information has been provided.If additional information is provided, a supplemental and final report will be filed.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure 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 were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.A two-year lot history review shows this is the only complaint for this lot number and failure mode.A two-year review of complaint history for this device family and failure mode, revealed there has been a total of 1 complaint, regarding 1 device, for this device family and failure mode.During this same time frame 1,969 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 0.0005.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.Per the ifu, the user is also advised to avoid damage or breakage during use, do not use excessive force on graft passing guide pin.Inspect pin prior to use and after removal to ensure it is in good physical condition and functions properly.Do not use if product is damaged.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
On behalf of the customer, the conmed representative reported issues involving the xactpin graft passing guide pin, included in the acl kit, item # 8820, lot # 1036515 that specialty surgical center - (b)(6) experienced (b)(6) 2019.It was reported that the doctor did an acl reconstruction with the items contained in the acl kit.During the procedure, the tip of the exactpin graft passing guide pin from the anatomic disposable kit broke off during the drilling of the pin into the femoral condyle.The surgeon could not locate the broken tip." to date, although multiple attempts have been made to gather additional information, no information has been provided.This report is being raised on the basis of injury for the tip fragment possibly left in the patient.

• Brand Name: ANATOMIC ACL DISPOSABLE KIT
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 9109896
• Report Number: 1017294-2019-00118
• Device Sequence Number: 3107070
• Product Code: KDD
• UDI-Device Identifier: 20845854041014
• UDI-Public: (01)20845854041014(17)210112(30)1(10)1036515
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2021
• Device Model Number: 8820
• Device Catalogue Number: 8820
• Device Lot Number: 1036515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial 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