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	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/29/2024, it was reported by a sales representative via ()b(4) that an ar-9297-25 avl angled reamer sleeve assembly, 25 and an ar-9676 angled reamer drive shaft cold welded and would not come apart out of the augmented vaultlock glenoid instruments.This was discovered during a procedure with no patient harm.
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9297-25 / batch 052224 was received for investigation.The reamer ar-9676 was received stuck inside.The shoulder of the ar-9676 is sitting flush against the sleeve.Because the devices were stuck, it was not possible to measure the id of the sleeve or od of the reamer.Visual evaluation found multiple dents and scratches around the shaft and in the collar sleeve.The observed 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: 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: 18953472
• Report Number: 1220246-2024-01621
• Device Sequence Number: 7050659
• Product Code: LXH
• UDI-Device Identifier: 00888867350045
• UDI-Public: 00888867350045
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 12/03/2024

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: 052224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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