MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE 5.5MM SER 3000; SAW, POWERED, AND ACCESSORIES

Model Number 7206010

Device Problem Break (1069)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

Event Type  Injury  

Event Description

It was reported that during a shoulder scope surgery, when the surgeon started to use the blade, it dropped metal in the shoulder.Additionally, it was stated that the blade was being used on soft tissue, no bone work.Another blade was used to complete the surgery and to remove all metal pieces.No significant delay or other complications reported.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 was received for evaluation.There was a relationship found between the device and the reported event.A visual evaluation showed the device was returned with a lidstock which shows the batch number of the complaint.The color scheme matches the print.The inner blade came separated from the outer blade.The outer blade and adapter show no visible deficiency.It is very clean and shiny through the cannula and outside.The inner blade shows dark discoloration and some scoring from friction on the distal end.The length of the inner blade has some discoloration.The blade edge shows sign of use but no definitive metal loss.A functional evaluation, using a reference control system, showed the blade functioned in all modes.No flakes were observed.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 found similar reported events.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.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that may have contributed to the reported event include excessive side loading or insufficient irrigation during use.No containment or corrective actions are recommended at this time.H11: h2: corrected data on d8 and h6 (health effect - clinical code and impact code).

• Brand Name: FULL RADIUS BLADE 5.5MM SER 3000
• 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: 10656153
• MDR Text Key: 210626028
• Report Number: 1219602-2020-01550
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010440235
• UDI-Public: 03596010440235
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 7206010
• Device Catalogue Number: 7206010
• Device Lot Number: 50854319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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
• Patient Outcome(s): Required Intervention