MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE COMP PLATE, 2-HOLE STR, 20MM; PLATE, FIXATION, BONE

Model Number	DYNANITE® COMP PLATE, 2-HOLE STR, 20MM
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/30/2020
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 09/21/2021, it was reported by a sales representative via e-mail that a surgeon implanted three dynanite compression plates in a patient on (b)(6) 2020 and the same patient came back to the surgeon in (b)(6) with all three plates broken.No additional information provided.Additional information requested.Additional information provided 09/24/2021: the date of the primary procedure was (b)(6) 2020 for a midfoot fusion.This procedure took place at (b)(6) hospital, arthrex account # (b)(4).Late (b)(6) 2020 the surgeon performed a revision where the following arthrex device(s) were explanted.X-ray attached.Ar-8771-2020ms, lot: 10722480 qty.1, ar-8771-0220s, lot: 10722375 qty.2.
Additional Manufacturer Narrative
Complaint is confirmed.The complaint devices were not returned for investigation, however an x-ray of the alleged complaint devices was provided.Based on the x-ray provided, the ar-8771-2020s can be seen implanted on the middle toe of the patient's foot, and it can be seen that the plate is broken at the junction of each hole.The second ar-8771-2020s can be seen implanted but cannot be confirmed whether it is broken or not based on this x-ray.As the complaint devices were not returned for investigation the cause of the breakage cannot be determined.

• Brand Name: DYNANITE COMP PLATE, 2-HOLE STR, 20MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12616882
• Report Number: 1220246-2021-03792
• Device Sequence Number: 11631216
• Product Code: HRS
• UDI-Device Identifier: 00888867307957
• UDI-Public: 00888867307957
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K193345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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: 02/28/2025
• Device Model Number: DYNANITE® COMP PLATE, 2-HOLE STR, 20MM
• Device Catalogue Number: AR-8771-0220S
• Device Lot Number: 10722375
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 10/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other