MAUDE Adverse Event Report: ARTHREX, INC. CON OBT F/TAP/FEN HF 4MM SCP SHTH W/HDLE; ACCESSORIES, ARTHROSCOPIC

Model Number	CON OBT F/TAP/FEN HF 4MM SCP SHTH W/HDLE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
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 conical obturator is broken off.There was no harm for patient, operator or third party.No further information received.Update on (b)(6) 2022: it was confirmed that the device broke during a surgery during insertion.The breakage point was outside of the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection it was noted that the shaft broke off near the handle.The cause of this is undetermined.

• Brand Name: CON OBT F/TAP/FEN HF 4MM SCP SHTH W/HDLE
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• 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: 14469606
• Report Number: 1220246-2022-04957
• Device Sequence Number: 20077391
• Product Code: NBH
• UDI-Device Identifier: 00888867030381
• UDI-Public: 00888867030381
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: CON OBT F/TAP/FEN HF 4MM SCP SHTH W/HDLE
• Device Catalogue Number: AR-3375-4001
• Device Lot Number: 1278302
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown