MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE® COMP PLATE, 2-HOLE STR, 30MM; PLATE, FIXATION, BONE

Model Number	DYNANITE® COMP PLATE, 2-HOLE STR, 30MM
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/06/2021
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 friday (b)(6) 2022, it was reported by an arthrex sales representative lina severs via email, (received direct from the patient) that part number ar-8771-0427x (batch# 12878793) - dynanite compression plate, 4 hole square, 27mm was removed in a revision surgery due to alleged pain.This was discovered during the period between the initial surgery.We are awaiting further information from the surgeon on this case which has been requested in writing.

• Brand Name: DYNANITE® COMP PLATE, 2-HOLE STR, 30MM
• 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: 15758817
• Report Number: 1220246-2022-05731
• Device Sequence Number: 8221476
• Product Code: HRS
• UDI-Device Identifier: 00888867307971
• UDI-Public: 00888867307971
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2022

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 Model Number: DYNANITE® COMP PLATE, 2-HOLE STR, 30MM
• Device Catalogue Number: AR-8771-0230S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 11/09/2022
• 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