MAUDE Adverse Event Report: ARTHREX, INC. PIN DRIVER ATTACHMENT 1.0-2.4 MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	PIN DRIVER ATTACHMENT 1.0-2.4 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
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 reported event was confirmed.The manufacturer evaluation revealed a loose pin at the outer sleeve as well as a torn welded joint.The weld seam can be clearly seen on both parts and can also be seen completely on the circumference.A most likely cause is attributed to wear and tear.
Event or Problem Description
It was reported that during a surgery a bolt of the device for securing the lock has fallen out.As a result, the wire is no longer stuck in the holder.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 28-apr-2023: it was confirmed that the bolt fell out during a mica (minimally invasive chevron and akin) surgery.The surgery was finished successfully by inserting k-wires with a smaller diameter and continuing the drilling process.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: PIN DRIVER ATTACHMENT 1.0-2.4 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: 19387830
• Report Number: 1220246-2024-03796
• Device Sequence Number: 3982508
• Product Code: HWE
• UDI-Device Identifier: 00888867100176
• UDI-Public: 00888867100176
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: PIN DRIVER ATTACHMENT 1.0-2.4 MM
• Device Catalogue Number: AR-300PD24
• Device Lot Number: 10698642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• 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