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

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2024

Event Type  malfunction  

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 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.

• Brand Name: DEPTH DEV,2.7/3.5 /4.0MMLO-PRO
• Type of Device: 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
• MDR Text Key: 337886608
• Report Number: 1220246-2024-01524
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 00888867052253
• UDI-Public: 00888867052253
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1