MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE COMP PLATE, 4-HOLE SQUARE, 22MM; PLATE, FIXATION, BONE

Model Number	DYNANITE COMP PLATE, 4-HOLE SQUARE, 22MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/02/2022
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
On (b)(6) 2022, it was reported by a sales representative via phone that an ar-8771-0422x dynanite compression plate was implanted on patient during a tarsal metatarsal fusion procedure on (b)(6) 2021.On (b)(6) 2022, it was noticed to be broken via x-ray.Patient underwent tarsal metatarsal fusion revision surgery on (b)(6) 2022 and had the ar-8771-0422x dynanite compression plate along with the staples from an ar-8719ds-181815 dynanite nitinol staple implant system removed.Surgeon completed the revision surgery by implanting devices from another manufacturer.Case was completed successfully and no further issues has been reported.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the compression plate had broken along the base of the screw wings into the center slot on both sides.The thickness of the device was measure and was found to be within the drawing specifications.The diameter of the sides of center slot were also measured and found to be within tolerance.The cause of this break remains undetermined.

• Brand Name: DYNANITE COMP PLATE, 4-HOLE SQUARE, 22MM
• Common Device Name: PLATE, FIXATION, BONE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14523306
• Report Number: 1220246-2022-04940
• Device Sequence Number: 20241083
• Product Code: HRS
• UDI-Device Identifier: 00888867339897
• UDI-Public: 00888867339897
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K193345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: DYNANITE COMP PLATE, 4-HOLE SQUARE, 22MM
• Device Catalogue Number: AR-8771-0422X
• Device Lot Number: 11897935
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown