MAUDE Adverse Event Report: ARTHREX, INC. DEPTH DEV,2.7/3.5 /4.0MMLO-PRO; DEPTH GAUGE

Model Number	DEPTH DEV,2.7/3.5 /4.0MMLO-PRO
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via sems-06502306 that an ar-8943-15 depth device pin came apart from the measurement handle.This was discovered during an ankle fracture repair procedure on (b)(6) 2024.The device did not break inside the patient.The case was completed by reinserting the depth pin into the handle and remeasured.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8943-15 batch 012301 was received for evaluation.Upon visual inspection, it was noted that the instrument was disassembled.It was noted that the instrument's needle was detached at the weld.No functional test was performed for the instrument due to the damage.The most likely cause is misuse due to user error of using excessive force to pry and leverage the device.

• Brand Name: DEPTH DEV,2.7/3.5 /4.0MMLO-PRO
• 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: 18923516
• Report Number: 1220246-2024-01533
• Device Sequence Number: 20711592
• Product Code: HTJ
• UDI-Device Identifier: 00888867052253
• UDI-Public: 00888867052253
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 12/05/2024

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 Model Number: DEPTH DEV,2.7/3.5 /4.0MMLO-PRO
• Device Catalogue Number: AR-8943-15
• Device Lot Number: 012301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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