MAUDE Adverse Event Report: ARTHREX, INC. MOTOR WITH CABLE 3.5M; POWERED SURG ORTHOPEDIC INSTR

Model Number	MOTOR WITH CABLE 3.5M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.This event is confirmed.The manufacturers evaluation revealed that the cable sheath at the plug is loose which caused the reported event.Furthermore, the bearing is loud and worn.It was reported that the cable sheath is broken.This event is confirmed.The manufacturers evaluation revealed that the cable sheath at the plug is loose which caused the reported event.Furthermore, the bearing is loud and worn.The most likely cause for the reported failure can be attributed to misuse/mishandling of the device.
Event or Problem Description
It was reported that the cable sheath is broken.This was noted after the surgery.There was no harm or adverse event for patient, operator or third party reported.No further information received.

• Brand Name: MOTOR WITH CABLE 3.5M
• 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: 19331217
• Report Number: 1220246-2024-03400
• Device Sequence Number: 7003635
• Product Code: HWE
• UDI-Device Identifier: 00888867200708
• UDI-Public: 00888867200708
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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: MOTOR WITH CABLE 3.5M
• Device Catalogue Number: AR-200M
• Device Lot Number: 10666996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown