MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE 5.5 FULL RADIUS ELITE DISPOSABLE; SAW, POWERED, AND ACCESSORIES

Catalog Number 7210909

Device Problem Flaked (1246)

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

It was reported that during an unspecified arthroscopy, the 5.5 mm blade elite had a strong metal abrasion.The root cause of the failure is unclear.The procedure was completed with a s+n back up device.There was a delay less than 30 minutes and no further complications were reported.

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Manufacturer Narrative

H6, health effect - impact code updated.H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.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.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

Manufacturer Narrative

The reported device was received for evaluation.A visual evaluation showed the device was returned with original packaging with the batch number of the complaint on the label.The color scheme of the device matches the print.There are grooves cut into the outer diameter, at the distal and proximal end, of the inner blade.There is a nick in the window edge of the outer blade.There are grooves cut into the inside window and the inside cannula of the outer blade which match the location of grooves cut on the inner blade.Heavy bio debris and metal flakes are present.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.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.The root cause was associated with unintended use of the device.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 precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.

• Brand Name: BLADE 5.5 FULL RADIUS ELITE DISPOSABLE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• 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: 18348770
• MDR Text Key: 331058768
• Report Number: 1219602-2023-02479
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010582737
• UDI-Public: 03596010582737
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7210909
• Device Lot Number: 51093687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1