MAUDE Adverse Event Report: ARTHREX, INC. SAW ATTACHMENT-SAG MINIMAL INVASIVE CUTS; POWERED SURG ORTHOPEDIC INSTR

Model Number	SAW ATTACHMENT-SAG MINIMAL INVASIVE CUTS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 01/28/2025, it was reported by a sales representative via (b)(4) that two (qty.2) ar-600sagmis sagittal saw attachments are falling apart and unable to connect blade attachments.They occurred during use in a case.No harm was done to the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is confirmed.One unpackaged ar-600sagmis minimal invasive cuts sagittal saw attachment serial number: (b)(6) was received for investigation.Visual evaluation of the returned device noted significant superficial damage with scratches, and nicks observed.Functional testing was performed by attempting to insert a known good ar-600-312s sagittal speedcut blade into the returned device and it was not possible to insert the blade as intended.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.

• Brand Name: SAW ATTACHMENT-SAG MINIMAL INVASIVE CUTS
• 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: 21353717
• Report Number: 1220246-2025-00361
• Device Sequence Number: 9127078
• Product Code: HWE
• UDI-Device Identifier: 00888867111103
• UDI-Public: (01)00888867111103(11)221025(10)15015716
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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-SAG MINIMAL INVASIVE CUTS
• Device Catalogue Number: AR-600SAGMIS
• Device Lot Number: 15015716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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