MAUDE Adverse Event Report: ARTHREX, INC. SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE; ACCESSORIES, ARTHROSCOPIC

Model Number SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE

Device Problems Break (1069); Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2022

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

Case (b)(4) on (b)(6) 2022 it was reported by a facility representative via sems that an ar-3373-4002 obturator snap in half during use, the washer came out.This was discovered during use in a procedure, with no patient harm reported.Additional information 04/25/2022 on 04/25/2022 it was reported by a facility representative via email that an ar-3373-4002 obturator snap in half and the washer came out, during use in a knee procedure at lahey clinic with dr.Samuelson.The case was completed using a backup set.Requested additional information on the removal of broken fragments from the patient.Additional information 04/28/2022 on 04/28/2022 it was reported by a facility representative via email that an ar-3373-4002 obturator snap in half and the washer came out, during use in a knee procedure.Nothing was left in the patient all fragment will be returned.The case was completed using a backup set.

Manufacturer Narrative

Complaint confirmed.Upon visual inspection, it was noted that the washer is missing.The washer was not returned for investigation.Upon functional testing it was noted that the washer would assemble and hold the device as required.The cause of this can be attributed to misuse.

• Brand Name: SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
• 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: 14336141
• MDR Text Key: 295495718
• Report Number: 1220246-2022-04857
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867198579
• UDI-Public: 00888867198579
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

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 Model Number: SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
• Device Catalogue Number: AR-3373-4002
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 04/18/2022
• Supplement Dates FDA Received: 07/19/2022
• 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