MAUDE Adverse Event Report: ARTHREX, INC. AR-400 DRILLSAW SPORTS RECIPROCATING SAW; POWERED SURG ORTHOPEDIC INSTR

Model Number	AR-400 DRILLSAW SPORTS RECIPROCATING SAW
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
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
It was reported that during a knee prothesis surgery the saw blade was stuck in the device because the device could not be opened.The saw blade could only be removed after several minutes.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device from another company.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the reported event was not confirmed.The manufacturer evaluation revealed the saw is worn at the saw blade holder.However, the saw blade is not sticking in the device, and the device can be opened as normal.

• Brand Name: AR-400 DRILLSAW SPORTS RECIPROCATING SAW
• 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: 22494695
• Report Number: 1220246-2025-02851
• Device Sequence Number: 17170492
• Product Code: HWE
• UDI-Device Identifier: 00888867428218
• UDI-Public: (01)00888867428218(11)240813(10)15307831
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: AR-400 DRILLSAW SPORTS RECIPROCATING SAW
• Device Catalogue Number: AR-400SR
• Device Lot Number: 15307831
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown