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	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a surgery the two attachments do not hold the k-wires in place.Also the k-wires and the attachment heat up during drilling.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device (ar-600dj).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Since the device was not received, an evaluation on the product could not be performed and the reported event cannot be verified.A most likely cause might be attributed to a supplier manufacturing issue.

• 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: 18705196
• Report Number: 1220246-2024-00968
• Device Sequence Number: 20268994
• Product Code: HWE
• UDI-Device Identifier: 00888867110977
• UDI-Public: 00888867110977
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: PIN DRIVER ATTACHMENT 0.8-4.0 MM
• Device Catalogue Number: AR-600PD-3
• Device Lot Number: 15062015
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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