MAUDE Adverse Event Report: ARTHREX, INC. FLEXIBLE SHAFT; PNEUMATIC PWR SURG INSTR MOTOR

Model Number	FLEXIBLE SHAFT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/21/2025, a sales representative reported via (b)(4) that an 0222-200 flexible reamer shaft broke.This occurred during a case where the piece was recovered and the case was completed with no issue.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged 0222-200 serial/batch number (b)(6) was received for evaluation.A visual evaluation revealed that the device tip was broken off.Corrosion was observed on the laser marks.The threads at the proximal end were bent.Scratches and marks were also noted on the shaft, and the shaft length was bent.Functional testing cannot be performed as the device was broken when received.The most likely cause of the reported failure is the device's wear and tear after many re-processings and uses.

• Brand Name: FLEXIBLE SHAFT
• Common Device Name: PNEUMATIC PWR SURG INSTR MOTOR
• 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: 21537400
• Report Number: 1220246-2025-00832
• Device Sequence Number: 18053139
• Product Code: LXH
• UDI-Device Identifier: 00848665023688
• UDI-Public: 00848665023688
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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: FLEXIBLE SHAFT
• Device Catalogue Number: 0222-200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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