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	Foreign Body In Patient (2687)
Date of Event	09/07/2022
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 email that qty.7 to 8 ar-8771-0220s dynanite comp plates have broken in pediatric patients receiving foot fusions procedures, which we have been removed over the course of the past month or so.This was discovered after use in various cases with different surgeons.No additional information provided.Additional information requested.
Additional Manufacturer Narrative
Review of this complaint confirmed the event summary code selection and an investigation including a product history review was performed as required.The complaint device was not returned for investigation, however, picture(s) of the complaint device were provided and used for investigation.The investigation confirmed the reported condition.The probable cause of the event was not able to be determined.The investigation did not change the potential harm(s) identified.Complaint trending for this event will be performed per wi-000100100.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15484275
• Report Number: 1220246-2022-05541
• Device Sequence Number: 5212248
• Product Code: HRS
• UDI-Device Identifier: 00888867307957
• UDI-Public: 00888867307957
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 12/29/2022

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, 20MM
• Device Catalogue Number: AR-8771-0220S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 12/29/2022
• 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