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	07/16/2025
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 07/16/2025, it was reported by a sales representative via (b)(4) that an ar-9597-20 angled reamer sleeve was cold welded with inside of the reamer.This was discovered during the case with no patient harm.Additional information was received 7/21/25 that this was discovered during a reverse total shoulder arthroplasty.After the 20 degree mgs augment reamer malfunctioned, the 25 degree primary augment reamer was used to complete reaming.Additional information was provided on 7/24/25 that the sleeve was stuck to the drive shaft.Part number and sn provided.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event description, and any additional field data, arthrex concluded that the most likely cause of the reported failure.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 cease 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 usually, this issue is unlikely to present itself, which suggests that the handling of the device greatly impacts whether or not it will seize.For this reason, the direct cause is considered to be device misuse.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• 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: 22717432
• Report Number: 1220246-2025-03250
• Device Sequence Number: 18544608
• Product Code: LXH
• UDI-Device Identifier: 00888867343450
• UDI-Public: (01)00888867343450(11)221111(10)37222223
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 37222223
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown