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

Catalog Number	7210499
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a shoulder arthroscopy, the full radius elite blade no longer worked properly and "flakes" were seen on the screen.An arthroscopic lavage was applied in the shoulder, and removed as much of the flake as possible, but residue was still present.The procedure was completed with a delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection revealed that the device was returned in original packaging with the batch number of the complaint on the label.The color scheme of the device matches the print.There are heavy scoring/grooves, in multiple areas, on the inner blade caused by debris caught between the inner and outer blade during use.This is scoring on the inside window of the outer blade from debris.The teeth on the blade are still sharp and bio debris is 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 similar reported events.The instructions for use were 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 clinical review states that due to the limited information provided, a clinical root cause of the reported flaking of the full radius elite blade cannot be determined.The patient impact is the blade residue remaining inside the patient.The blade is not intended for long term internal exposure, and long-term implantation data is not available.The patient impact is possible micro-motion and/or migration, and possible local irritation/discomfort.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include excessive side-loading and minimal irrigation.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that during a shoulder arthroscopy, the full radius elite blade no longer worked properly and "flakes" were seen on the screen.An arthroscopic lavage was applied in the shoulder, and removed as much of the flake as possible, but there were still metal pieces left inside the patient.The procedure was completed with a delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.

• Brand Name: DISPOSABLE BL 4.5MM FR ELITE
• Common Device Name: 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: 18530643
• Report Number: 1219602-2024-00129
• Device Sequence Number: 12450337
• Product Code: HAB
• UDI-Device Identifier: 03596010494764
• UDI-Public: 03596010494764
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 7210499
• Device Lot Number: 51103590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown