MAUDE Adverse Event Report: ARTHREX, INC. SAW ATTACHMENT-SAGITTAL; POWERED SURG ORTHOPEDIC INSTR

Model Number	SAW ATTACHMENT-SAGITTAL
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via sems-06922391 that an ar-400sag drill attachment is not functioning properly.Discovered during a case with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.During evaluation, drive shaft is seized, head claw screw is damaged from drive shaft eccentric screw.Head shell and housing have multiple scratches/scuff marks.Unable to service as some parts are not available.The complaint allegation has been confirmed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.During evaluation, drive shaft is seized, head claw screw is damaged from drive shaft eccentric screw.Head shell and housing have multiple scratches/scuff marks.Unable to service as some parts are not available.

• Brand Name: SAW ATTACHMENT-SAGITTAL
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 22414541
• Report Number: 1220246-2025-02749
• Device Sequence Number: 13210295
• Product Code: HWE
• UDI-Device Identifier: 00888867223424
• UDI-Public: (01)00888867223424(11)190116(10)10270673
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 09/24/2025

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: SAW ATTACHMENT-SAGITTAL
• Device Catalogue Number: AR-400SAG
• Device Lot Number: 10270673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2025
• Distributor Facility Aware Date: 06/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 09/12/2025; 09/18/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/16/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown