MAUDE Adverse Event Report: ARTHREX, INC. AVL ANGLED REAMER SLEEVE ASSEMBLY, 15; ORTHOPEDIC MANUAL SURG INSTR

Model Number	AVL ANGLED REAMER SLEEVE ASSEMBLY, 15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint not confirmed.Upon visual inspection, it was noted that there was damage to the surface at the proximal and distal ends of the sleeve.The devices were not returned assembled together.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the device during use.
Event or Problem Description
On 2/04/2022 it was reported by a sales representative via (b)(4) that an ar-9676 angled reamer and an ar-9297-15 angled reamer sleeve heat welded together during a total shoulder procedure.The patient had extremely hard bone.The physician was using the angled reamer to prepare for the 15 degree vaultlock implant, but was having to an unusual amount of force in order to get the correction he needed for the implant to sit flush.Once the case was over and the trays were put back together in spd it was realized that the inner and outer reamer sleeves were essentially heat welded together.This did not affect the flow or outcome of the case, as it did not change the performance of the reamer intra-operatively.

• Brand Name: AVL ANGLED REAMER SLEEVE ASSEMBLY, 15
• 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: 19492318
• Report Number: 1220246-2024-05290
• Device Sequence Number: 17914804
• Product Code: LXH
• UDI-Device Identifier: 00888867350038
• UDI-Public: 00888867350038
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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, 15
• Device Catalogue Number: AR-9297-15
• Device Lot Number: 052043
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown