MAUDE Adverse Event Report: CONMED CORPORATION GENESYS MATRYX 9.0X20MM INTERFERENCE SCREW; FIXATION DEVICE

Model Number	239020M5
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided.Therefore, the reported failure cannot 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 1 complaint regarding 1 device for this device family and failure mode.During the same time frame 2,043 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.0005 per the instructions for use, the user is advised the following; that improper insertion technique may cause breakage of the screw and/or driver or premature failure.Genesys¿matryx® screws should only be used with the designated surgical instruments as outlined in the "instruments used with genesys¿matryx® screws" section herein.It is important that the screw is driven with the appropriate driver and the guidewire.Full insertion of the appropriate driver within the lumen of the genesys¿matryx® screw is mandatory for proper screw delivery.Care must be taken to line up the lobes of the driver with the slots in the screw.Failure to ensure full engagement may result in screw and/or driver breakage.Examine the driver prior to screw engagement for gouges, scratches or dents.Bure the tip is not bent so as not to impede the engagement of the screw.The presence of these defects increases the risk of screw and/or driver breakage.This issue will continue to be monitored through the complaint system to ssure patient safety.
Event or Problem Description
The conmed representative reported on behalf of the facility that the 239020m5, geneses interference screw, was being tightened by hand screwdriver into the bone tunnel, the screw blew up into three pieces in the bone tunnel.The tunnel was reamed and tapped prior to the screw breaking into pieces.All of the pieces were not removed.The part of the screw that was fixated to the tendon in the bone tunnel was left in place.The other fragments were removed.The procedure was completed with a synthese screw and post.There was no patient injury and there was a delay in surgical time due to the malfunction but the length of time was not reported.This report is being raised as device malfunction with potential for injury upon reoccurrence.

• Brand Name: GENESYS MATRYX 9.0X20MM INTERFERENCE SCREW
• Common Device Name: FIXATION DEVICE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 8922824
• Report Number: 1320894-2019-00299
• Device Sequence Number: 11249955
• Product Code: HWC
• UDI-Device Identifier: 10845854016657
• UDI-Public: (01)10845854016657(17)230506(30)1(10)201805071
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2019

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: 05/06/2023
• Device Model Number: 239020M5
• Device Catalogue Number: 239020M5
• Device Lot Number: 201805071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1