MAUDE Adverse Event Report: ARTHREX, INC. ANGLED REAMER SLEEVE, 10°; MANUAL INSTR, GENERAL SURGICAL

Model Number	ANGLED REAMER SLEEVE, 10°
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
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 03/07/2025, a sales representative reported via (b)(4) that an ar-9676 angle reamer drive shaft spun and stripped inside the ar-9597-10 angle reamer sleeve 10 degrees while reaming the glenoid.They had to leave the glenoid as it was.The reversal was completed in full.It did add 5 minutes to the case.This was discovered during a revers procedure, with no reported patient harm.Additional information was received on 03/13/2025: they had to leave the glenoid as it was reamed and could not use another option.There was no report of adverse effects on or after the surgery for the patient.This occurred during an rtsa procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: the complaint allegation is confirmed.One unpackaged ar-9597-10, serial/batch number (b)(6), was received for investigation.The visual evaluation noted abrasion marks along the inside of the shaft and heavy circumferential grind marks on the proximal end of the device.Functional testing was not performed due to the damage to the device.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 do this during normal clinical use.When used normally, 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 a misuse of the device.

• Brand Name: ANGLED REAMER SLEEVE, 10°
• 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: 21664380
• Report Number: 1220246-2025-01103
• Device Sequence Number: 18070886
• Product Code: LXH
• UDI-Device Identifier: 00888867343436
• UDI-Public: 00888867343436
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 07/02/2025

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, 10°
• Device Catalogue Number: AR-9597-10
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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