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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/24/2021
Type of Reportable Event	Serious Injury
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) 2021, it was reported by a sales representative via e-mail that an ar-8771-0422x dynanite comp plate and an ar-8771-0427x dynanite comp plate broke post-operative.The date of the primary procedure was (b)(6) 2020 for a tn and cc fusion.This procedure took place at (b)(6) hospital, arthrex account # (b)(4).Date of revision is unknown.

• 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
• MDR Report Key: 12616469
• Report Number: 1220246-2021-03783
• Device Sequence Number: 3473387
• Product Code: HRS
• UDI-Device Identifier: 00888867339897
• UDI-Public: 00888867339897
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• 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, 4-HOLE SQUARE, 22MM
• Device Catalogue Number: AR-8771-0422X
• Device Lot Number: 10722396
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other