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

Model Number TORQUE INDICATING ADAPTOR

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  malfunction  

Event Description

On 11/20/2023, it was reported by a sales representative via (b)(4) that an ar-9545-t15h torque indicating adapter malfunctioned during use.The case was completed successfully, with no further information provided.This was discovered during a reverse tsa procedure on 11/14/2023, with no reported patient harm.

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.

• Brand Name: TORQUE INDICATING ADAPTOR
• Type of Device: 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: emily shafer ; 8009337001
• MDR Report Key: 18359461
• MDR Text Key: 331108970
• Report Number: 1220246-2023-09492
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867225091
• UDI-Public: 00888867225091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TORQUE INDICATING ADAPTOR
• Device Catalogue Number: AR-9545-T15H
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1