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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via sems (b)(4) that an ar-600pd-3 pin driver attachment fell out with no affect to patient reported.This was discovered during a 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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 3/27/2024: this was discovered during a tka procedure on (b)(6) 2024.The case was completed using another set with no delay or adverse effects on the patient.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-600pd-3 serial/batch number (b)(6) was received for investigation.The visual evaluation revealed that the insert fell out and the pin driver was missing.No functional testing was performed due to the damaged to the device.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• 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: 19130088
• Report Number: 1220246-2024-02104
• Device Sequence Number: 6825736
• Product Code: HWE
• UDI-Device Identifier: 00888867110977
• UDI-Public: 00888867110977
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2024

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 0.8-4.0 MM
• Device Catalogue Number: AR-600PD-3
• Device Lot Number: 14937301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 03/27/2024; 07/29/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/02/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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