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

Catalog Number	7210909
Medical Device Problem Codes	Flaked (1246); Material Twisted/Bent (2981); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during shoulder arthroscopy, the use of the blade 5.5 full radius locked the handpiece and white powder came out when the blade was force to be used.It broke several times during the surgery.The procedure was a completed without surgical delay 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
H10 h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.A clinical evaluation states that the ifu for the dyonics elite blade does warn, ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extra cases may result in wear and degradation of the inner assembly.Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised material in the surgical site.¿ please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If any additional information related to this event is received in the future, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was returned with original packaging with the batch number of the complaint on the label.The color scheme of the device matches the print.The adaptor body has come loose from the outer cannulated blade.The adaptor body hole, for the outer blade tube, is cracked.Multiple teeth on the inner blade are bent and deformed which has wore against the outer blade edges as it spun and deformed them.Bio debris is present.A functional evaluation showed that the outer blade comes out of the adaptor body.The inner blade is stuck inside the outer blade and will not turn due to its bent and deformed teeth.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.Although, a procedural variance vs user error could not be rule out.The biocompatibility of the unidentified white powder is unknown.Nor was it communicated whether the unidentified white powder was retained/removed from inside of the patient.Therefore, if the unidentified white powder was retained, we cannot rule out the possibility of local irritation/discomfort, and/or migration of the possible retained unidentified white powder.According to the report, the procedure was a completed without surgical delay using a smith and nephew back up device for the blade and the same mdu, without further complications.No further impact to the patient is anticipated.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (unintended impact).Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.

• Brand Name: BLADE 5.5 FULL RADIUS ELITE DISPOSABLE
• 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: 19906928
• Report Number: 1219602-2024-01652
• Device Sequence Number: 12521937
• Product Code: HAB
• UDI-Device Identifier: 03596010582737
• UDI-Public: 03596010582737
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2025

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: 7210909
• Device Lot Number: 51143057
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 09/06/2024; 04/23/2025
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/09/2024; 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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 Age: 45 YR
• Patient Sex: Female