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

Model Number	SAW ATTACHMENT-SAGITTAL
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 12/12/2023, it was reported by a sales representative via (b)(4) that an ar-400sag saw attachment blade is dull and will not cut bone.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-400sag serial/batch number 02653 was received for investigation.Functional testing was not conducted on this device due to the absence of a corresponding mating part.Upon visual inspection, signs of wear and tear were evident, along with dent marks on the device's head.The reported failure is most commonly attributed to misuse by the end user, considering the device was manufactured in 2023.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18464610
• Report Number: 1220246-2024-00186
• Device Sequence Number: 7117040
• Product Code: HWE
• UDI-Device Identifier: 00888867223424
• UDI-Public: 00888867223424
• 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): 08/27/2024

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: 15135863
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• 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