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 Break (1069)

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

Event Date 02/01/2024

Event Type  malfunction  

Event 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.

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.

• 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: 18738992
• MDR Text Key: 335754867
• Report Number: 1220246-2024-01035
• Device Sequence Number: 1
• Product Code: HTJ
• 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: 02/20/2024

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
• Device Operator: 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?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2023
• 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