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 Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
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 09/24/2024, it was reported by a sales representative via sems-06671072 that an ar-600sagmis sagittal saw attachment came apart during a case.This was discovered during a procedure, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-600sagmis sagittal saw attachment serial number: (b)(6) was received for investigation.Visual evaluation of the returned device noted that the device was coming apart, as a component was received detached.Further visual evaluation noted wear and tear to the device with superficial scratches and slight discoloration observed.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repeated usage/reprocessing.Manufactured date: 25-oct-2022.

• 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: 20439274
• Report Number: 1220246-2024-08115
• Device Sequence Number: 8183868
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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