MAUDE Adverse Event Report: ARTHREX, INC. PIN DRIVER ATTACHMENT 0.8-4.0 MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	PIN DRIVER ATTACHMENT 0.8-4.0 MM
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 6th august 2025, it was reported by a distributor via email that for an ar-600pd-3, pin driver attachment 0.8 - 4.0 mm, ar-600 wire driver attachment was not firmly gripped.Upon test drill, the wire wobbled and shook a lot which may cause inaccurate trajectory during drilling.This was detected during use in a knee acl all inside procedure on (b)(6) 2025.The procedure was completed successfully with hospital unit power tool.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: drive shaft has metal shavings inside chuck affecting proper function.Connector locking pin broken causing attachment to no lock onto drill, multiple scratch/scuff marks on housing.

• Brand Name: PIN DRIVER ATTACHMENT 0.8-4.0 MM
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 22873233
• Report Number: 1220246-2025-03593
• Device Sequence Number: 13354934
• Product Code: HWE
• UDI-Device Identifier: 00888867110977
• UDI-Public: (01)00888867110977
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: PIN DRIVER ATTACHMENT 0.8-4.0 MM
• Device Catalogue Number: AR-600PD-3
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown