MAUDE Adverse Event Report: ARTHREX, INC. TORQUE INDICATING ADAPTOR; POWERED SURG ORTHOPEDIC INSTR

Model Number	TORQUE INDICATING ADAPTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2024
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 01/30/2024, it was reported by a sales representative via (b)(4) that an ar-9545-t15h torque indicating adapter broke.This occurred during a revers total shoulder arthroplasty procedure on (b)(6) 2024 when the torque indicator broke when approaching 5.The case was completed successfully.No additional information was provided, and additional information has been asked.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint is confirmed.Visual inspection identified that laser marks faded and the edges around the torque indicating adapter had chipped.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.Functional testing noted that the torque indicating is stuck.
Event or Problem Description
Additional information was provided on 2/7/2024 where it was stated that no fragments were in the patient.The device broke when reaching the end of the available torque range.
Additional Manufacturer Narrative
Additional information was provided on 2/7/2024 where it was stated that no fragments were in the patient.The device broke when reaching the end of the available torque range.

• Brand Name: TORQUE INDICATING ADAPTOR
• Common Device Name: POWERED SURG ORTHOPEDIC 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: 18725990
• Report Number: 1220246-2024-01013
• Device Sequence Number: 6292324
• Product Code: HWE
• UDI-Device Identifier: 00888867225091
• UDI-Public: 00888867225091
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2024

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: TORQUE INDICATING ADAPTOR
• Device Catalogue Number: AR-9545-T15H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 03/22/2024; 02/07/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 11/29/2024; 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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