MAUDE Adverse Event Report: ARTHREX, INC. REAMER ATTACHMENT - STYLE A/O PROTEK; POWERED SURG ORTHOPEDIC INSTR

Model Number	REAMER ATTACHMENT - STYLE A/O PROTEK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
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 new device ar-400raop broke during the surgery when the surgeon worked on the hip.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (ar-600raop).It was not necessary to switch the surgical technique or do a second surgery.Update avoe 02-sep-2024 it was confirmed that the surgeon took the motor with the ar-400raop tip to prepare the acetabulum and during preparation the tip broke!.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.It was reported that during a hip arthroplasty surgery the new device ar-400raop broke during the surgery when the surgeon worked on the hip.The reported event was confirmed.The manufacturer evaluation revealed a broken drive shaft along with a broken planetary gear and 2 broken bearing bolts.A hardness measurement of the drive shaft components did not show any issues and a definite cause for the observed breakage cannot be determined.

• Brand Name: REAMER ATTACHMENT - STYLE A/O PROTEK
• 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: 20157377
• Report Number: 1220246-2024-07425
• Device Sequence Number: 4209534
• Product Code: HWE
• UDI-Device Identifier: 00888867223530
• UDI-Public: 00888867223530
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/14/2025

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 A/O PROTEK
• Device Catalogue Number: AR-400RAOP
• Device Lot Number: 15225882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2024
• 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