MAUDE Adverse Event Report: ARTHREX, INC. DEPTH GUIDE, MINI; DEPTH GAUGE

Model Number	DEPTH GUIDE, MINI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/06/2025, it was reported by a sales representative via sems-06776294 that an ar-13120g-2 depth guide broke off.This occurred during use in a case with no patient effect.The broken piece was removed and did not affect the case outcome.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-13120g-2 depth guide mini batch number: 02143707 was received for investigation.Visual evaluation of the returned device noted wear and tear to the device with superficial discoloration and faded laser markings observed.It was further noted that the tip of the depth guide had broken off.Dimensional testing was performed with a caliper and found that the length of the depth guide component was 133.68, indicating that a fragment of about 0.53 had broken off as the length specified in drawing c4903 is 134.21.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repeated usage/reprocessing.Date of manufacture: 2014.

• Brand Name: DEPTH GUIDE, MINI
• 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: 21431649
• Report Number: 1220246-2025-00575
• Device Sequence Number: 4605077
• Product Code: HTJ
• UDI-Device Identifier: 00888867007727
• UDI-Public: (01)00888867007727(10)02143707
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/10/2025

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 GUIDE, MINI
• Device Catalogue Number: AR-13120G-2
• Device Lot Number: 02143707
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown