MAUDE Adverse Event Report: ARTHREX, INC. REAMER ATTACHMENT - STYLE ZIMMER/HUDSON; POWERED SURG ORTHOPEDIC INSTR

Model Number	REAMER ATTACHMENT - STYLE ZIMMER/HUDSON
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
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
It was reported that during a hip arthroplasty surgery the tip on the bottom of the chuck broke.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different device ar-400rhu.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed.The manufacturer evaluation revealed both gear box and driveshaft are broken and damaged, the planetary gear was found frozen and a pin was missing.A most likely cause for the observed condition would be attributed to using the attachment in oscillating mode.

• Brand Name: REAMER ATTACHMENT - STYLE ZIMMER/HUDSON
• 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: 21409597
• Report Number: 1220246-2025-00527
• Device Sequence Number: 9382179
• Product Code: HWE
• UDI-Device Identifier: 00888867223523
• UDI-Public: (01)00888867223523(11)240805(10)15302660
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 07/30/2025

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: REAMER ATTACHMENT - STYLE ZIMMER/HUDSON
• Device Catalogue Number: AR-400RZH
• Device Lot Number: 15302660
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• 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