MAUDE Adverse Event Report: ARTHREX, INC. DEPTH DEVICE, 2.0 / 2.4MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	DEPTH DEVICE, 2.0 / 2.4MM
Medical Device Problem Codes	Incorrect Measurement (1383); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/2/2023, it was reported by a sales representative via phone that an ar-18724-08 low profile screw, ar-18724-12 low profile screw, and an ar-18724-18 low profile screw all had the same issue due to the ar-18700-35 depth gauge device.During an orif for an acromial fracture on (b)(6) 2023, the three low-profile screws were removed due to being too long when an x-ray was performed while the patient was under anesthesia.The screws were measuring longer than the bone anatomy due to the depth gauge device being incorrectly assembled by sterilization.The case was completed using shorter replacement screws from the same set with a three-minute delay in the procedure, and no additional anesthesia was administered.The entire procedure took 90 minutes, and no fragments broke.This was discovered during an orif for an acromial fracture procedure on (b)(6) 2023.
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
Additional information: g3, h3, h6.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 for the reported failure can be attributed to misuse due to user error as the customer stated the screws were measuring longer than the bone anatomy due to the depth gauge device being incorrectly assembled by sterilization.

• Brand Name: DEPTH DEVICE, 2.0 / 2.4MM
• 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: 18022606
• Report Number: 1220246-2023-08420
• Device Sequence Number: 6586073
• Product Code: MDM
• UDI-Device Identifier: 00888867312807
• UDI-Public: 00888867312807
• 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): 02/10/2025

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, 2.0 / 2.4MM
• Device Catalogue Number: AR-18700-35
• Device Lot Number: 052143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• 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