MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO REFURB SWICHING STICK 3.6 REF 4308; ACCESSORIES,ARTHROSCOPIC

Catalog Number 6900727

Device Problem Sharp Edges (4013)

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

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during an arthroscopy procedure, the mto refurb switching stick 3.6 ref 4308 was too skinny and it was too flexible, it was quite flimsy and sharp.This happened with a total of 2 devices.The procedure was completed with a backup device with no delay nor patient injury.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3,h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 complaint history review concluded this was an isolated event.A relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: MTO REFURB SWICHING STICK 3.6 REF 4308
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11594768
• MDR Text Key: 243116272
• Report Number: 1219602-2021-00757
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885554006438
• UDI-Public: 885554006438
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

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 Catalogue Number: 6900727
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 04/30/2021
• Supplement Dates FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1