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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
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 5/9/2024, it was reported by a sales representative via sems-06563758 that an ar-9545-t15h torque indicating adapter broke and, therefore, caused the ar-9545-t15-01 driver shaft to torque out.They had a second set of trays available and completed the case without harm.This was discovered during a procedure, with no reported patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-9545-t15h serial/batch number (b)(6) was received for investigation.Visual evaluation found that the laser marks are fading, which is indicative of repeated use of the device.Additionally, it was noted that the mating part, ar-9545-t15-01, was received attached to it.Functional testing found that the device is not moving in any direction.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.The manufacturing date is 2019.

• 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: 19477609
• Report Number: 1220246-2024-05073
• Device Sequence Number: 17910364
• Product Code: HWE
• UDI-Device Identifier: 00888867225091
• UDI-Public: 00888867225091
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 10/14/2024

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
• Device Lot Number: 8001923
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• 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