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

Model Number	2.7MM SCREW DEPTH INDICATOR
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/6/2023, it was reported by an arthrex employee via sems (b)(4) that an ar-2670 screw depth indicator (the device is a loaner) and an ar-8943-15 depth device (the device is a loaner) was not measuring correctly due to the two tips being swapped that was confirmed by their inspection team.This was discovered during an unspecified procedure, 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
Additional information: g3, h3, h6 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 the reported failure can be attributed to mishandling the device.The complaint allegation was not confirmed.The device was not received for evaluation, and the customer¿s attached picture does not provide evidence of the failure.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18257700
• Report Number: 1220246-2023-09121
• Device Sequence Number: 3893828
• Product Code: HTJ
• UDI-Device Identifier: 00888867098534
• UDI-Public: 00888867098534
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 2.7MM SCREW DEPTH INDICATOR
• Device Catalogue Number: AR-2670
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 02/06/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown