MAUDE Adverse Event Report: ARTHREX, INC. SABRE, SJ 3.0MM 7CM; SAW BLADE

Model Number	SABRE, SJ 3.0MM 7CM
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
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.Complaint confirmed.One unpackaged ar-7300sr was received for investigation.Visual inspection identified the presence of severe heat damage across the shaft of the ar-7300sr.The hub was melted at the connection point with the outer tube shaft.Removal of the inner tube from the outer tube revealed that the device broken along the inner tube shaft, with the fragments retained within the inner diameter of the outer tube.The observed condition is consistent with insufficient fluid flow during use.
Event or Problem Description
On 11/2/2021, it was reported by a sales representative via (b)(4) that an ar-7300sr sabre heats up so much that it glows red from the heat.This was discovered during a procedure.The patient was not affected.

• Brand Name: SABRE, SJ 3.0MM 7CM
• Common Device Name: SAW BLADE
• 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 engel ; 8009337001
• MDR Report Key: 19052263
• Report Number: 1220246-2024-01839
• Device Sequence Number: 7069018
• Product Code: GFA
• UDI-Device Identifier: 00888867041974
• UDI-Public: 00888867041974
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 04/05/2024

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 Expiration Date: 05/31/2026
• Device Model Number: SABRE, SJ 3.0MM 7CM
• Device Catalogue Number: AR-7300SR
• Device Lot Number: 13481138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown