MAUDE Adverse Event Report: ARTHREX, INC. SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS; ACCESSORIES, ARTHROSCOPIC

Model Number	SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2022
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
On 7/5/2022, it was reported by a sales representative via medwatch email that the tip of an ar-3371-4000 arthroscope sheath broke off inside the patient.The broken fragment was retrieved.This was discovered during a shoulder joint fracture procedure on (b)(6)2022.No further information has been given.

• Brand Name: SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS
• 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: 15092747
• Report Number: 1220246-2022-05271
• Device Sequence Number: 4034885
• Product Code: NBH
• UDI-Device Identifier: 00888867030145
• UDI-Public: 00888867030145
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/25/2022

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 BODY, TAP/FEN, HF/4MM SCP STH SYS
• Device Catalogue Number: AR-3371-4000
• Device Lot Number: 1307212
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown