MAUDE Adverse Event Report: ARTHREX, INC. SHEATH,HF,TAP/FEN,1STPCK F/STORZ 4MM SCP; ACCESSORIES, ARTHROSCOPIC

Model Number	SHEATH,HF,TAP/FEN,1STPCK F/STORZ 4MM SCP
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/14/2022
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 during arthroscopy, the following was discovered during surgery, a small screw on the side at the top of the working tube is gone.A screw that normally is not being removed during washing and sterilization.Patient underwent x-ray to ensure screw is not in patient, which is not the case.It is unknown whether screw was missing at the start of surgery, as nurse is not aware of this part, as the screw is usually not removed when instruments unpacked.
Additional Manufacturer Narrative
This is a follow-up to update submission 1220246-2022-005270.We evaluated the reported incident and due to the provided information we came to the conclusion that this case has to be determined as not reportable.It was reported that the screw was found to be missing during an arthroscopy, however it is unclear when the reported screw went missing.As nothing broke off during the surgery we assume that the screw had to be unscrewed.As it could be confirmed with the x-rays that the missing screw was not left in the patient and as it is unlikely that the surgeon has unscrewed the screw during the surgery we determined that the event has occurred sometime prior to this surgery.Furthermore we clearly state in the dfu of the reported device that the device has to be checked by the user prior to use if some parts are loose or not properly fixated and that it is not allowed to use the device if something is missing.

• Brand Name: SHEATH,HF,TAP/FEN,1STPCK F/STORZ 4MM SCP
• 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: 15064957
• Report Number: 1220246-2022-05270
• Device Sequence Number: 5628197
• Product Code: NBH
• UDI-Device Identifier: 00888867029477
• UDI-Public: 00888867029477
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 07/26/2022

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,1STPCK F/STORZ 4MM SCP
• Device Catalogue Number: AR-3320-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 07/26/2022
• 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