MAUDE Adverse Event Report: ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT; MANUAL INSTR, GENERAL SURGICAL

Model Number	ANGLED REAMER, DRIVE SHAFT
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
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 05/22/2025, a facility representative reported via (b)(4) that an ar-9676 angled reamer drive shaft and an ar-9597-10 angled reamer sleeve were bent.They were discovered during the case.There were no adverse effects on the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.Visual evaluation noted that the shaft was not bent.Strong abrasion marks were noted around the shaft of the angled reamer, drive shaft.The device was chipped around the distal end of the shaft and the fitting hybrid hudson.Functional testing was performed, and it did not slide freely with the mating part returned ar-9597-10.The most likely cause for the reported failure can be attributed to misuse due to a force perpendicular to the drive shaft being applied while the device is spinning.This applied force creates an excess of friction and heat that ultimately has the potential to cause the device to seize from functioning as intended.Application of this force perpendicular to the drive shaft is not needed for the device to function, nor is it recommended that the user does this during normal clinical use.When used normally, this issue is unlikely to present itself, which suggests that the handling of the device has a large impact on whether or not it will seize.For this reason, the direct cause is considered to be misuse of the device.¿.

• Brand Name: ANGLED REAMER, DRIVE SHAFT
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 22282541
• Report Number: 1220246-2025-02508
• Device Sequence Number: 8467660
• Product Code: LXH
• UDI-Device Identifier: 00888867324954
• UDI-Public: (01)00888867324954(11)240214(10)022406
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: ANGLED REAMER, DRIVE SHAFT
• Device Catalogue Number: AR-9676
• Device Lot Number: 022406
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown