MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH BSKT NRWLN UPBTR; ACCESSORIES,ARTHROSCOPIC

Model Number 012051

Device Problems Dull, Blunt (2407); Material Twisted/Bent (2981)

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

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that during the surgery the pch bskt nrwln upbtr is not cutting properly, hhi instrument is bent from the shaft.No patient injuries or significant delay was reported.Surgery was completed using a competitor device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: 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 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.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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 markings on the device confirm the product identification information, and the device is worn from use.There is an upward bent in the shaft.A functional evaluation of the returned device found that it actuates with some resistance.The device is able to cut cleanly through the testing material.A review of the customer provided image found labelling confirming the product identification information.No damage can be seen on the device in the image.The complaint of material deformation was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include wear from repeated use of the device over time and inadequate routine maintenance of the device.The complaint of dull/blunt was not confirmed, and the root cause could not be determined.Factors that could have contributed to the reported event include excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.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: PCH BSKT NRWLN UPBTR
• Type of Device: 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: 11397820
• MDR Text Key: 234201999
• Report Number: 1219602-2021-00423
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010024138
• UDI-Public: 03596010024138
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 012051
• Device Catalogue Number: 012051
• Device Lot Number: 50838762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 01/30/2023
• Supplement Dates FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention