MAUDE Adverse Event Report: ARTHREX, INC. PIN DRIVER ATTACHMENT, 0-3.2MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	PIN DRIVER ATTACHMENT, 0-3.2MM
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 04/08/2025, it was reported by a sales representative via (b)(4) that an ar-400pd drillsaw sports 400 system would not hold the pin.They tried a few times to get it to hold and then switched to a different one that worked to complete the case.The patient was not affected.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.Manufactured date: 25-sep-2018.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.
Event or Problem Description
Additional information was received: the acl reconstruction procedure occurred in the first week of april.The case proceeded without delays, additional anesthesia, or a representative present.During the procedure, an attachment was used with a pin driver; however, the mouth of the attachment failed to open properly to accept the pin.Despite this issue, the procedure was completed without further complications.

• Brand Name: PIN DRIVER ATTACHMENT, 0-3.2MM
• 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: 21884053
• Report Number: 1220246-2025-01646
• Device Sequence Number: 14335203
• Product Code: HWE
• UDI-Device Identifier: 00888867102163
• UDI-Public: (01)00888867102163(11)180925(10)10241652
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2025

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, 0-3.2MM
• Device Catalogue Number: AR-400PD
• Device Lot Number: 10241652
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2018
• 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