MAUDE Adverse Event Report: ARTHREX, INC. Y-PLATE, 2.4MM, 6 HOLE; PLATE, FIXATION, BONE

Model Number	Y-PLATE, 2.4MM, 6 HOLE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/24/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a mini cfs for posterior malleolus fixation in a trimalleolar fracture case, the head of ar-18724-34 went through the plate, ar-18724p-49, as the surgeon was attempting to pull the plate to bone.The screw was removed without incident and the surgeon was able to swap the ar-8933-36 in it¿s place and added 2mm to account bigger 3.0 head.After the plate was down to bone, an additional 2.4 cortical, qty.1 and 3.0 cortical screws, qty.2 were placed also without incident and fixation was solid.

• Brand Name: Y-PLATE, 2.4MM, 6 HOLE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12198382
• Report Number: 1220246-2021-03421
• Device Sequence Number: 4227571
• Product Code: HRS
• UDI-Device Identifier: 00888867314689
• UDI-Public: 00888867314689
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K191344
• 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): 07/20/2021

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: Y-PLATE, 2.4MM, 6 HOLE
• Device Catalogue Number: AR-18724P-49
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1