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

Model Number	ANGLED REAMER, ORIENTATION SLEEVE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
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 04/17/2025, a facility representative reported via (b)(4) that an ar-9679 orientation sleeve, angled reamer was broken.This was discovered in a case with no adverse effects on the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9679, batch 051946, was received for investigation.Visual evaluation noted that the handle was cracked.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure is wear and tear.Due to continuous mechanical forces applied to it, the device will inevitably sustain damage over time.Refer to investigation photos.The complaint allegation is confirmed.

• Brand Name: ANGLED REAMER, ORIENTATION SLEEVE
• 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: 21960409
• Report Number: 1220246-2025-01881
• Device Sequence Number: 17960256
• Product Code: LXH
• UDI-Device Identifier: 00888867324909
• UDI-Public: 00888867324909
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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, ORIENTATION SLEEVE
• Device Catalogue Number: AR-9679
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown