MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE 3.5 CURVED CONCAVE FULL RADIUS; SAW, POWERED, AND ACCESSORIES

Catalog Number	7210980
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during a knee arthroscopy, the shaver got clogged, tech went to unclog it and noticed the tip on the inside of the full radius blade had broken off inside the shaver sheet.No pieces were left in the patient, they were not in the patient freely.Another blade was opened and the same thing happened.The procedure was completed without surgical delay using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection revealed that they are not in their original packaging.The inner shaft of both devices is fractured near the distal end of the heat shrink sleeve.The distal blade portion of the inner shafts is stuck in the outer shaft of the devices.There is biological debris on the returned items.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.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 has been associated with unintended use of the device.Factors that could have contributed to the failure include an inadvertent impact event inconsistent with normal use or an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.

• Brand Name: BLADE 3.5 CURVED CONCAVE FULL RADIUS
• 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: 19168676
• Report Number: 1219602-2024-00865
• Device Sequence Number: 20678123
• Product Code: HAB
• UDI-Device Identifier: 03596010595775
• UDI-Public: 03596010595775
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7210980
• Device Lot Number: 51169563
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2023
• 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
• Patient Sex: Unknown