MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM INC PLUS PLAT CURVED BLD; SAW, POWERED, AND ACCESSORIES

Catalog Number	72205109
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the shaver was working initially for the first minute, but after that, two (2) plus curved blade stopped rotating.The surgeon was using the blade on the meniscus, no bone resection was involved.Nurses said it seemed like the distal end of the inner blade snapped at the bend/neck.However nothing fell into the patient, the inner blade stayed inside the outside blade.The procedure was completed using a competitor device.There was a delay of less tan 30 minutes.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).The reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The inner shaft is fractured just above the cutting surface.There is biological debris in the shaft and the burr.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 failures and/or harms were documented appropriately, and there were no indications to suggest the anticipated risks are not adequate.The root cause was associated with unintended use of the device.Factors that could have contributed to the failure include an application of excessive force or contact with another source.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
Results of investigation updated: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.Biological debris in the shaft and on the burr indicate the device was used in treatment.The inner shaft is fractured just above the cutting surface.No manufacturing abnormalities were detected during visual inspection.A review of the associated batch manufacturing records confirmed that the lot met all specifications upon release for distribution and there were no deviations or non-conformance's reported for this lot.A complaint history review found an increase in similar reported events originating from ireland, however, the global complaint rate for the rest of world is stable and within expected limits.A risk management review found that the reported failure and associated potential harms were documented appropriately, and there were no indications to suggest the anticipated risks are not adequate.The blades design verification report was reviewed and found the shrink wrap thickness was assessed.The shrink wrap thickness on the current print conforms to the verification testing and it was also noted that each lot of shrink wrap is accompanied with a certificate of conformance from the supplier.A definitive root cause for the reported issue could not be determined.Based on our investigation, there is no evidence to suggest a design, material or manufacturing issue.Factors that could have contributed to the failure include the application of excessive force/side-loading the device during use, inadequate irrigation/suction, or contact with another source (e.G.Another instrument/hard metal surface).No containment or corrective actions are recommended at this time.H6, investigation conclusions code corrected.

• Brand Name: 4.5MM INC PLUS PLAT CURVED BLD
• 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: 19336689
• Report Number: 1219602-2024-01056
• Device Sequence Number: 12415789
• Product Code: HAB
• UDI-Device Identifier: 00885556708903
• UDI-Public: 00885556708903
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Followup
• Report Date (Section B): 08/11/2024

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: 72205109
• Device Lot Number: 51190059
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: 06/12/2024; 08/06/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/17/2024; 08/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2024
• 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