MAUDE Adverse Event Report: ARTHREX, INC. SHEATH,HF,TAP/FEN,2 STPCK F/4.8MM SCOPE; ACCESSORIES, ARTHROSCOPIC

Model Number	SHEATH,HF,TAP/FEN,2 STPCK F/4.8MM SCOPE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/09/2021
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 during a shoulder arthroscopy performed on (b)(6) 2021, the sheath broke.There were no fragments reported, and the procedure was completed using a new device of the same part number.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection identified that the distal end of the sheath had broken.The fragment generated was not returned for analysis.The surrounding area of the sheath tip was noticeably dented/bent.The observed condition is consistent with interference between the device and other instrumentation during use.

• Brand Name: SHEATH,HF,TAP/FEN,2 STPCK F/4.8MM SCOPE
• 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: 12364441
• Report Number: 1220246-2021-03570
• Device Sequence Number: 3536654
• Product Code: NBH
• UDI-Device Identifier: 00888867206984
• UDI-Public: 00888867206984
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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: SHEATH,HF,TAP/FEN,2 STPCK F/4.8MM SCOPE
• Device Catalogue Number: AR-3373-5002
• Device Lot Number: 1492397
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown