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	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.See attached for vendor evaluation.The most likely cause for the reported failure can be attributed to misuse of the device due to damage to the device.
Event or Problem Description
It was reported on 10/20/2021 by a facility representative via (b)(4) that an ar-600sagmis saw attachment does not grab the blade and that complicates the cut.This was discovered during a case with no patient harm.

• 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: 19331306
• Report Number: 1220246-2024-03401
• Device Sequence Number: 12515063
• Product Code: HWE
• UDI-Device Identifier: 00888867111103
• UDI-Public: 00888867111103
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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-SAG MINIMAL INVASIVE CUTS
• Device Catalogue Number: AR-600SAGMIS
• Device Lot Number: 10007896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown