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	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/7/2023, it was reported by a sales representative via sems- (b)(4) that an ar-1999hh ratcheting handle, hybrid hudson, and an ar-9545-t15h torque indicating adaptor had an issue.While inspecting the ar-1999hh ratcheting handle inside the warehouse, it was discovered that the instrument appears to be jammed and has difficulty disengaging from the ar-9545-t15h torque indicating adaptor.This issue continued after further testing in the warehouse, and the devices are no longer operational.This was discovered during inspection, with no patient harm reported.
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.
Additional Manufacturer Narrative
Complaint is not confirmed.Upon visual inspection, the laser mark was fading and some discoloration on the device.Functional testing with mating parts ar-9545-t15-05 found that the device worked as required.No problem found.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18258180
• Report Number: 1220246-2023-09134
• Device Sequence Number: 3890524
• Product Code: HWE
• UDI-Device Identifier: 00888867225091
• UDI-Public: 00888867225091
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/19/2024

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
• Device Lot Number: 8002052
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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