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	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via (b)(4) that an ar-8943-15 depth device, 2.7 / 3.5 / 4.0 mm, low profile from the titanium ankle fracture tray, ar-9943s, was not measuring correctly.Every screw was measured improperly because of the depth gauge.The gauge is supposed to be 20mm according to what it is reading in the back.It is 2mm off.This caused every screw to be off.This was discovered during a distal fibula fx with syndesmosis and deltoid repair with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.Complaint allegation is not confirmed.Dimensional testing: components were measured and met dimension.690 ±.010 per drawing c6043 rev 11.Visual inspection revealed abrasion marks on the tip of the depth device, 2.7 / 3.5 / 4.0 mm, low profile.Functional testing was performed, and no issues were found with the slider pin that translate smoothly into the body.No problem found.

• 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: 18922720
• Report Number: 1220246-2024-01524
• Device Sequence Number: 15055388
• Product Code: HTJ
• UDI-Device Identifier: 00888867052253
• UDI-Public: 00888867052253
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 07/01/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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