MAUDE Adverse Event Report: ARTHREX, INC. INSERT 2.4 MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	INSERT 2.4 MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
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
It was reported that the 2.4 mm ring of the device detached from the sleeve and broke off during an arthroscopy surgery.No part broke inside the patient.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update 29-apr-2021: it was confirmed that the ring of the device broke of during pulling out while the surgeon was working with the device in the patient.There was no harm for the patient.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1204f-24i, batch 012035 insert was received for investigation.Visual inspection identified that the diamond knurled knob broke from the shaft at the laser beam weld.The inner diameter of the knurled knob was assessed, as well as the thickness of the component, and both values were determined to fall within design tolerances.Additionally, the diameter of the distal end of the shaft (at the interface point with the inner diameter of the knob) was assessed and found to fall within design tolerance.Surface damage was noted across the laser marked surface of the knurled knob, as well as along the outer diameter of the component.The observed condition of the insert is most likely the result of user applied mechanical forces to the device during use.

• Brand Name: INSERT 2.4 MM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11798494
• Report Number: 1220246-2021-03028
• Device Sequence Number: 1009805
• Product Code: MDM
• UDI-Device Identifier: 00888867004528
• UDI-Public: 00888867004528
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: INSERT 2.4 MM
• Device Catalogue Number: AR-1204F-24I
• Device Lot Number: 012035
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/23/2021
• Patient Sequence Number: 1