MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SWITCHING STICK; ACCESSORIES,ARTHROSCOPIC

Model Number	3801
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the newly purchased "4.3mm switching stick" was noticed to be rusty at the time of acceptance after arrival.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H2: additional information in h6 (health effect - impact code).H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection of the returned device found that it is not in its original packaging.The device has scratches along it's length, some near one end have discoloration around the damaged area.An assessment of the customer provided images shows the complaint device, with the discoloration around the tip as well as another device with discoloration around the hub.The complaint was confirmed, and the root cause could not be determined.Factors that may have contributed to the reported event include material degradation from repeated sterilization or improper cleaning techniques.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: SWITCHING STICK
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10788197
• Report Number: 1219602-2020-01770
• Device Sequence Number: 14487018
• Product Code: NBH
• UDI-Device Identifier: 03596010118592
• UDI-Public: 03596010118592
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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: 3801
• Device Catalogue Number: 3801
• Device Lot Number: 50821661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown