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

Model Number	SABRE, SJ 3.0MM 7CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/13/2024, it was reported by a sales representative via sems-06710476 that an ar-7300sr sabre caused metal fragments.This occurred during use in a case.The case was completed the repair using an open technique in order to flush out metal remnants.Slight delay to case, extra irrigation used to flush out the metal shavings.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint was confirmed based on photographic evidence showing metal fragments during a procedure.Arthrex determined that the most likely cause of the reported failure was user error, specifically due to due to side-loading the devices during use.

• 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 engle ; 8009337001
• MDR Report Key: 20868524
• Report Number: 1220246-2024-08752
• Device Sequence Number: 18298190
• Product Code: GFA
• UDI-Device Identifier: 00888867041974
• UDI-Public: (01)00888867041974(11)231109(17)281031(10)15165689
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/21/2025

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: SABRE, SJ 3.0MM 7CM
• Device Catalogue Number: AR-7300SR
• Device Lot Number: 15165689
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• 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