MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISPOSABLE BL 4.5MM FR ELITE; SAW, POWERED, AND ACCESSORIES

Model Number 7210499

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 08/21/2020

Event Type  Injury  

Event Description

It was reported that the disposable shaver was shedding in the joint leaving metal debris.The procedure was successfully completed without a significant delay using the same device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: b4: event description updated 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.The arthroscopic photo provided confirmed the reported failure.The complaint was confirmed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.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 review of risk management files found that the reported failure was documented appropriately.A review of the process summary, form, fill and seal packaging sequence for: arthroscopic surgical blades products, found that the blade device is to be inspected for component integrity and particulate or foreign matter.A review of the complaint revealed it was not confirmed if all the metal debris was completely removed.Therefore, since the metal debris from the elite disposable blade is not implantable, we cannot rule out the possibility of tissue inflammation, micro-motion or migration of the metal debris.Per report the procedure completed with the same device, less than a thirty-minute delay and there was no other harm to the patient.Therefore, no further clinical/medical assessment is warranted at this time.No containment or corrective actions are recommended at this time.

Event Description

It was reported that the disposable shaver was shedding in the joint leaving metal debris, all the pieces were removed with suction.The procedure was successfully completed without a significant delay using the same device.No patient injury or other complications were reported.

• Brand Name: DISPOSABLE BL 4.5MM FR ELITE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10532673
• MDR Text Key: 206927585
• Report Number: 1219602-2020-01398
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010494764
• UDI-Public: 03596010494764
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210499
• Device Catalogue Number: 7210499
• Device Lot Number: 50854323
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention