MAUDE Adverse Event Report: ARTHREX, INC. 2.7MM SCREW DEPTH INDICATOR; DEPTH GAUGE

Model Number	2.7MM SCREW DEPTH INDICATOR
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/27/2023, it was reported by a sales representative via phone that an ar-2670 screw depth indicator would not read accurately in the drill tunnel.As a result, an ar-8827l-24 low profile locking screw and an ar-8827l-20 low profile locking screw were wasted.This was discovered during a distal clavicle procedure on (b)(6) 2023.The case was completed with a product from another manufacturer.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to wear and tear incurred from repeated usage.

• Brand Name: 2.7MM SCREW DEPTH INDICATOR
• 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: 19498403
• Report Number: 1220246-2024-05393
• Device Sequence Number: 20536232
• Product Code: HTJ
• UDI-Device Identifier: 00888867098534
• UDI-Public: 00888867098534
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 06/10/2024

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: 2.7MM SCREW DEPTH INDICATOR
• Device Catalogue Number: AR-2670
• Device Lot Number: 10689811
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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