MAUDE Adverse Event Report: ARTHREX, INC. DRL/SCRW,DISTAL CLAV PLT,RT; ARTHROSCOPIC ACCESSORIES

Model Number	DRL/SCRW,DISTAL CLAV PLT,RT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/27/2024, it was reported by a facility representative via (b)(4) that an ar-2664r drill/screw guide, distal clavicle plate came back broken after a case.It was stated that the device had no issues when it went out for the case, and nothing was reported to the rep of any issues with the device during use.This was discovered after use, with no patient harm reported.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause is wear and tear.
Event or Problem Description
Additional information: the device never touched the patient and was found broken when they were doing their own internal audit and double checking the trays and noticed the device was broken.

• Brand Name: DRL/SCRW,DISTAL CLAV PLT,RT
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: jared engle ; 8009337001
• MDR Report Key: 18896192
• Report Number: 1220246-2024-01442
• Device Sequence Number: 17689292
• Product Code: NBH
• UDI-Device Identifier: 00888867098411
• UDI-Public: 00888867098411
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: DRL/SCRW,DISTAL CLAV PLT,RT
• Device Catalogue Number: AR-2664R
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown