MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL CUP REAMER XS/33; ORTHOPEDIC MANUAL SURG INSTR

Model Number	HUMERAL CUP REAMER XS/33
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
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 05/08/2024 it was reported by a sales representative via (b)(3) that an ar-9508-33 humeral cup reamer was dull and did not ream away the bone sufficiently from their humeral 2 tray.The case was completed using a backup tray with no issues.This was discovered during a reverse total shoulder procedure with no patient harm reported.Additional information was received on 5/13/2024: this occurred on (b)(6) 2024 during reverse total shoulder procedure.There was no delay in the case other than opening another tray.The ar-9508-33 humeral cup reamer did not break, but was worn and did not work as intended.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-9508-33 humeral cup serial/batch number (b)(6) was received for investigation.The visual inspection found signs of wear and tear.The cutting edges are dull, and damage was observed on the connecter hole.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.Devices with cutting functions or sharp points become dull with continuous use.This condition does not indicate a device defect.This condition indicates normal wear.

• Brand Name: HUMERAL CUP REAMER XS/33
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19467048
• Report Number: 1220246-2024-04910
• Device Sequence Number: 3566548
• Product Code: LXH
• UDI-Device Identifier: 00888867406681
• UDI-Public: 00888867406681
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 09/18/2024

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: HUMERAL CUP REAMER XS/33
• Device Catalogue Number: AR-9508-33
• Device Lot Number: AR08875001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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