MAUDE Adverse Event Report: ARTHREX, INC. ARTHROSCOPE, 30 DEG, 2.4 X 72MM

Model Number	ARTHROSCOPE, 30 DEG, 2.4 X 72MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke off at the joint during surgery.The broken pieces were retrieved from patient.There was no harm for patient, operator or third party.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.
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 confirmed.Functional testing was not performed due to the damage to the device and the shaft not being returned.Visual evaluation showed that the device was broken into multiple pieces.The most likely cause of this condition is the excessive force used to pry and/or leverage the device.The cause remains error use.Refer to investigation photos.

• Brand Name: ARTHROSCOPE, 30 DEG, 2.4 X 72MM
• Common Device Name: ARTHROSCOPE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16051084
• Report Number: 1220246-2022-05965
• Device Sequence Number: 20434093
• Product Code: HRX
• UDI-Device Identifier: 00888867029545
• UDI-Public: 00888867029545
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: ARTHROSCOPE, 30 DEG, 2.4 X 72MM
• Device Catalogue Number: AR-3350-2430
• Device Lot Number: 14975007
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown