MAUDE Adverse Event Report: ARTHREX, INC. AVL ANGLED REAMER SLEEVE ASSEMBLY, 25; ORTHOPEDIC MANUAL SURG INSTR

Model Number	AVL ANGLED REAMER SLEEVE ASSEMBLY, 25
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 3/7/2024, it was reported by a sales representative via (b)(4) that an ar-9297-25 univers vaultlock augmented glenoid angled reamer sleeve was locking up and causing issues while reaming; the inside of it was not smooth, and the inner sleeve was not able to move freely within the angled reamer sleeve.This was discovered during a procedure (b)(6) 2024, with no reported patient harm.Additional information was received on 3/11/2024: this was discovered during a augmented eclipse procedure on (b)(6) 2024.The case was completed by using an alternative reamer sleeve from a separate set.There was no case delay.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-9297-25 serial/batch number (b)(6) was received for investigation.Functional testing reveals that the parts get stuck to mating part, ar-9676, due to the damage on the outer and inner surfaces of the device.Visual evaluation revealed abrasion marks on the base of the angled reamer, inside of the inner diameter of the device.The most likely cause is attributed to misuse due to interference with the mating instrument.

• Brand Name: AVL ANGLED REAMER SLEEVE ASSEMBLY, 25
• 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: 18960716
• Report Number: 1220246-2024-01648
• Device Sequence Number: 20669804
• Product Code: LXH
• UDI-Device Identifier: 00888867350045
• UDI-Public: 00888867350045
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/09/2024

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: AVL ANGLED REAMER SLEEVE ASSEMBLY, 25
• Device Catalogue Number: AR-9297-25
• Device Lot Number: 052227
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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