MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE® COMP PLATE. 2-HOLE STR, 16MM; BONE FIXATION SCREW/PLATE

Model Number	DYNANITE® COMP PLATE. 2-HOLE STR, 16MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information h3: the device has not been returned due to revision not taking place.Received one x-ray photograph of the implant within the patient.Device appears broken and the complaint is confirmed.The cause of the failure cannot be determined with the given information.The most likely cause of the failure is a patient specific event.
Event or Problem Description
It was reported on (b)(6) 2022 by a sales representative via email that an ar-8771-0216s dynamite compression plate broke 6 months post op.No case involvement, no reported patient effect.No revision date has been scheduled yet.Event description requires update as identified during remediation activities required under capa-00417."it was reported on (b)(6) 2022 by a sales representative via email that an ar-8771-0216s dynamite compression plate broke 6 months post op.This was discovered postoperatively with no patient injury.No revision date has been scheduled yet.".

• Brand Name: DYNANITE® COMP PLATE. 2-HOLE STR, 16MM
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: emily shafer ; 8009337001
• MDR Report Key: 18030086
• Report Number: 1220246-2023-08441
• Device Sequence Number: 7018009
• Product Code: HRS
• UDI-Device Identifier: 00888867339866
• UDI-Public: 00888867339866
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K193345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNANITE® COMP PLATE. 2-HOLE STR, 16MM
• Device Catalogue Number: AR-8771-0216S
• Device Lot Number: 12698620
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown