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

Model Number	ANGLED REAMER SLEEVE, 10°
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/18/2024, a sales representative reported via sems-06737551 that an ar-9676 angle reamer, drive shaft, and an ar-9597-10 angle reamer sleeve, 10°, seized together while in use using standard technique with normal bone quality.The patient was not harmed.The case was completed using a different set of instruments.This was discovered during a procedure on 12/12/2024, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information was received on 12/23/204: this was discovered during a reverse total shoulder procedure on (b)(6) 2024.There was no case delay reported and no adverse effects on the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-9597-10 batch 3762227 was received for investigation.The reamer ar-9676 was received separately.Visual evaluation found multiple scratches around the inside diameter and in the collar sleeve.The knurl also had numerous dents and burns.Functional testing was not performed as the devices inside diameter was damaged.The reported condition is most likely the result of overheating during use caused by overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.

• 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: 21148842
• Report Number: 1220246-2025-09432
• Device Sequence Number: 9262881
• Product Code: LXH
• UDI-Device Identifier: 00888867343436
• UDI-Public: 00888867343436
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2025

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
• Device Lot Number: 3762227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 12/23/2024; 01/28/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 01/21/2025; 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown