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

Model Number	TORQUE INDICATING ADAPTOR
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
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 05/23/2024, it was reported by a sales representative via sems-06577204 that an ar-9545-t15-01 driver shaft and an ar-9545-t15h torque indicating adapter were unable to be taken apart.This occurred after use in an rtsa procedure with no effect on the patient.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-9545-t15h serial/batch number (b)(6) was received for investigation.Visual inspection found that the ar-9545-t15-01 is stuck to the device.Laser markings on the device are discolored/ oxidized.Functional testing could not be performed due to the damage of the device.The most likely cause is attributed to wear and tear due to repeated use of the device.The manufacturing date is march 2017.

• 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: 19568018
• Report Number: 1220246-2024-06143
• Device Sequence Number: 6305895
• Product Code: HWE
• UDI-Device Identifier: 00888867225091
• UDI-Public: 00888867225091
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/19/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 09/19/2024
• 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