MAUDE Adverse Event Report: ARTHREX, INC. 2.5MM HEX SCREW DRIVER; INTRAMED FIXATN ROD AND ACCESS

Model Number	2.5MM HEX SCREW DRIVER
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
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 device was not returned for evaluation; no pictures were provided.The most likely cause for the reported failure can be attributed to user error; however, due to the device not being returned, we are unable to confirm the reported event.
Event or Problem Description
On 03/28/2023, it was reported by a sales represetnatiev via sems that an 0416-200 2.5mm hex screw driver was not engaging the 3.5mm cortical screw.This occurred during a case, a different driver was used to complete the case.

• Brand Name: 2.5MM HEX SCREW DRIVER
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 19574238
• Report Number: 1220246-2024-06260
• Device Sequence Number: 4159678
• Product Code: HSB
• UDI-Device Identifier: 00848665032345
• UDI-Public: 00848665032345
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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
• Operator of Device: Health Professional
• Device Model Number: 2.5MM HEX SCREW DRIVER
• Device Catalogue Number: 0416-200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown