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

Catalog Number	7210980
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy medial meniscectomy, the inner lumen of the curved full radius blade did not rotate in oscillation, forward or reverse.The procedure was completed using a smith and nephew back up device.There was a 2-min surgical delay and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed it was not in its original packaging.The inner shaft was twisted into 2 separate pieces, with the distal end stuck in the curved outer shaft.There was biological debris.A functional evaluation was performed on the returned device and found it was unable to function due to the fractured inner shaft.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.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 application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.

• 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: 20064346
• Report Number: 1219602-2024-01825
• Device Sequence Number: 15362357
• Product Code: HAB
• UDI-Device Identifier: 03596010595775
• UDI-Public: 03596010595775
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 08/26/2024
• 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