MAUDE Adverse Event Report: CONMED CORPORATION GENESYS MATRIX SCREW 10X35MM INTERFERENCE SCREW; FIXATION DEVICE

Model Number	231035M5
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction: this medwatch was previously filed under 1017294-2020-00297, upon review of the complaint, the lot number for the device indicates it was manufactured in (b)(4); therefore, a correction is being filed under the (b)(4) registration number.Additional device code is hwc.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.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 7 complaints regarding 7 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; the screw must be fully inserted below the cortical surface to avoid protrusion and soft tissue irritation.Improper insertion technique may cause breakage of the screw and/or driver or premature failure.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Conmed (b)(6) reported on behalf of their customer that the 231035m5, genesys matryx screw 10x35mm, was used in an acl procedure on (b)(6) 2020.The screw broke during insertion.The screw tip was retrieved per the facility.There was a 2-minute delay and another of the same type of screw was used to complete the procedure.There was no reported patient injury or impact.Additional information stated that the surgeon will often use a screw 2 sizes above reamed diameter.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: GENESYS MATRIX SCREW 10X35MM INTERFERENCE SCREW
• Common Device Name: FIXATION DEVICE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica, ny
• MDR Report Key: 10435978
• Report Number: 1320894-2020-00297
• Device Sequence Number: 19493700
• Product Code: MAI
• UDI-Device Identifier: 10845854016893
• UDI-Public: (01)10845854016893(17)230812(30)1(10)201808131
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2023
• Device Model Number: 231035M5
• Device Catalogue Number: 231035M5
• Device Lot Number: 201808131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1