MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE COMP PLATE, 4-HOLE SQUARE, 27MM; BONE FIXATION PLATE

Model Number	DYNANITE COMP PLATE, 4-HOLE SQUARE, 27MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The reported event is confirmed based on the investigation of the returned x-ray.It was reported that the plate broke.Visual evaluation identified that the plate broke.The plate is currently still implanted in the patient.Additionally, without the return of the product, further investigation cannot be performed.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause for the reported failure can be attributed to a patient-specific event.According to dfu-0321 at revision 0.E.Warnings.7.Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.
Event or Problem Description
It was reported the patient underwent a primary surgery on (b)(6) 2020.The following arthrex product was implanted during the primary surgery.Ar-8771-0230s (lot: 10722395) / qty.1, ar-8771-0427x (lot: 10722415) / qty.1, ar-8719mxds-1818 (lot: 0051101455) / qty.1.The surgeon put the patient into boot during week 5/6.To the surgeons knowledge the patient was compliant.It was reported that there was one day the patient was doing house chores while in the boot and felt pain in their foot after standing for a long period of time but claimed to have no injury.During week 8/9 patient came into clinic and surgeon noticed a crack in the ar-8771-0230s.Then week 12 came around, and the second plate ar-8771-0427x had broken.Staple was intact throughout this time frame.On (b)(6) 2021, the patient came back into clinic and x-ray shows that the proximal staple arm of ar-8719mxds-1818 was broken as well.As of now patients pain level is okay, and the surgeon plans to remove hardware at one year post-op.See source data and x-ray image attached.Additional information received on 5/14/2021: the rep reported the original procedure type was a midfoot fusion.At this time, the revision surgery has not been scheduled yet.The rep stated they will notify arthrex once the product has been explanted.

• Brand Name: DYNANITE COMP PLATE, 4-HOLE SQUARE, 27MM
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19558615
• Report Number: 1220246-2024-05924
• Device Sequence Number: 11964928
• Product Code: HRS
• UDI-Device Identifier: 00888867339903
• UDI-Public: 00888867339903
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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, 4-HOLE SQUARE, 27MM
• Device Catalogue Number: AR-8771-0427X
• Device Lot Number: 10722415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown