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	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is now reportable.During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed.One unpackaged ar-3371-4000, batch 1485988 sheath was received for investigation.Visual inspection identified that the black o-ring component had broken out of the inner diameter of the sheath hub, allowing for fluid leakage during use.The observed condition is most likely the result of off-axis insertion of mating instrumentation, leading to o-ring breakage.
Event or Problem Description
It was reported that during a shoulder arthroscopic procedure, the surgeon noticed that the sheath, ar-3371-4000 was leaking water.The case was completed by using another sheath without further issue.This is now reportable.During returned device evaluation, a reportable malfunction was discovered.

• 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
• MDR Report Key: 11436911
• Report Number: 1220246-2021-02688
• Device Sequence Number: 17435767
• Product Code: NBH
• UDI-Device Identifier: 00888867030145
• UDI-Public: 00888867030145
• 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: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 1485988
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1