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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/1/2024, it was reported by a sales representative via (b)(4) that the skinny part of an ar-8943-15 depth device, that slides down to measure a screw broke.This was discovered during a procedure; the patient was not affected.Additional information requested.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint confirmed.One unpackaged ar-8943-15 batch 012301 was received for evaluation.Upon visual inspection, 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: 18738992
• Report Number: 1220246-2024-01035
• Device Sequence Number: 12357526
• Product Code: HTJ
• UDI-Device Identifier: 00888867052253
• UDI-Public: 00888867052253
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 02/20/2024
• 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