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	04/27/2021
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 device broke off.Update 18-may-2021: the guide rod broke off when entering the subacrominal space.The breakage point was outside the patient.Nothing needed to be removed from the patient.Nobody was harmed.A shoulder arthroscopy was performed, it was finished successfully.The technique was not changed and a second surgery was not necessary.

• 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
• MDR Report Key: 11947804
• Report Number: 1220246-2021-03230
• Device Sequence Number: 3235533
• 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: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/07/2021

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: CON OBT F/TAP/FEN HF 4MM SCP SHTH W/HDLE
• Device Catalogue Number: AR-3375-4001
• Device Lot Number: 1255532
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/07/2021
• Patient Sequence Number: 1