MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE COMP PLATE, 2-HOLE STR, 25MM; PLATE, FIXATION, BONE

Model Number	DYNANITE® COMP PLATE, 2-HOLE STR, 25MM
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported during a cc joint procedure the ar-8771-0225s nitinol double compression plate was attached to bone on one side with a bbtak.The other side was drilled with a 2.5 drill through val guide for a 3.0 hybrid kreulock screw.The kreulock screw did not compress the plate to bone and distracted.As the screw locked into the threads of the plate, the round hole snapped clean off the plate, leaving the plate unusable.There was no harm done to the patient and the screw was easily removed.

• Brand Name: DYNANITE COMP PLATE, 2-HOLE STR, 25MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11655733
• Report Number: 1220246-2021-02899
• Device Sequence Number: 17201207
• Product Code: HRS
• UDI-Device Identifier: 00888867307964
• UDI-Public: 00888867307964
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K193345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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 Model Number: DYNANITE® COMP PLATE, 2-HOLE STR, 25MM
• Device Catalogue Number: AR-8771-0225S
• Device Lot Number: 10834139
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1