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

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 304704465
• Report Number: 1220246-2022-05270
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867029477
• UDI-Public: 00888867029477
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/20/2022
• Supplement Dates Manufacturer Received: 06/29/2022
• Supplement Dates FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1