MAUDE Adverse Event Report: ARTHREX, INC. ANGLED REAMER SLEEVE, 20°; MANUAL INSTR, GENERAL SURGICAL

Model Number	ANGLED REAMER SLEEVE, 20°
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
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 02/26/2025, it was reported by a sales representative via (b)(4) that an ar-9597-20 reamer sleeve and ar-9676 reamer shaft are welded together.This occurred during use in a case with no patient effect.Additional information requested.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 one unpackaged ar-9597-20 angled reamer sleeve batch number: 37622051 was received for investigation.Visual evaluation of the returned device noted wear and tear to the device with superficial scratches, discoloration and faded laser markings observed.It was further noted that the device was received separate from the mating device and the two devices were not welded or stuck together.Functional testing was performed by attempting to insert the returned mating instrument into the returned ar-9597-20 angled reamer sleeve and it was found the have resistance and be met with friction.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 do 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.Refer to investigation photos.Complaint allegation is confirmed.

• Brand Name: ANGLED REAMER SLEEVE, 20°
• 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: 21596869
• Report Number: 1220246-2025-00931
• Device Sequence Number: 21067544
• Product Code: LXH
• UDI-Device Identifier: 00888867343450
• UDI-Public: (01)00888867343450(11)210422(10)37622051
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 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: ANGLED REAMER SLEEVE, 20°
• Device Catalogue Number: AR-9597-20
• Device Lot Number: 37622051
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown