MAUDE Adverse Event Report: ARTHREX, INC. DEPTH GAUGE FULL AUGMENT

Model Number	DEPTH GAUGE FULL AUGMENT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
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
On 07/21/2025, it was reported by a sales representative via (b)(4) that an ar-9597-10 angled reamer sleeve and an ar-9599f depth guage full augment were cold welded together.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9599f batch 20099411 was received for evaluation.The device arrived separated from the reported ar-9597-10 angled reamer sleeve.Visual inspection revealed discoloration spots all around the device.The complaint allegation was not confirmed.The device arrived separately for evaluation, and no evidence of failure was received.The most likely cause of the reported failure may be attributed to abnormal use.Specifically, the ar-9599f is not designed to be inserted into the ar-9597-10, and such misuse could result in device malfunction or damage.Refer to the investigation pictures.

• Brand Name: DEPTH GAUGE FULL AUGMENT
• Common Device Name: DEPTH GAUGE
• 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: 22742813
• Report Number: 1220246-2025-03331
• Device Sequence Number: 7404669
• Product Code: HTJ
• UDI-Device Identifier: 00888867346192
• UDI-Public: 00888867346192
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/06/2025

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: DEPTH GAUGE FULL AUGMENT
• Device Catalogue Number: AR-9599F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown