MAUDE Adverse Event Report: ARTHREX, INC. DEPTH DEVICE, 1.4 / 1.6MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	DEPTH DEVICE, 1.4 / 1.6MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 it was reported by a sales representative via sems (b)(4) that an ar-18700-27 depth device and an ar-18700-35 depth device were defective; both devices would stick when attempting to read depth and making it difficult for the surgeon to get an accurate reading.The case was completed utilizing the depth gauge from the 2.4/3.0 cfs set.This has occurred in previous cases.This was discovered during an metacarpal fracture procedure on (b)(6) 2023, with no reported patient harm.
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.Manufactured date 2019.

• Brand Name: DEPTH DEVICE, 1.4 / 1.6MM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: emily shafer ; 8009337001
• MDR Report Key: 18140091
• Report Number: 1220246-2023-08748
• Device Sequence Number: 7998833
• Product Code: MDM
• UDI-Device Identifier: 00888867313835
• UDI-Public: 00888867313835
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/25/2024

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 DEVICE, 1.4 / 1.6MM
• Device Catalogue Number: AR-18700-27
• Device Lot Number: 051914
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown