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); Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy procedure, the incisor curved blade was not functioning and not rotating correctly; the rubber, translucent seal on the blade base maligned.And the head of the inner tube was defective and breaking.The procedure was successfully completed using a back-up device.There was a surgical delay of less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
B5 and health effect - impact code were updated.H3, h6: a device deficiency was not identified, and the root cause of the reported events 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 failures and/or harms were documented appropriately, and there were no indications to suggest the anticipated risks are not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that during an arthroscopy procedure, the incisor curved blade was not functioning and not rotating correctly; the rubber, translucent seal on the blade base maligned.And the head of the inner tube was defective and broken.The inner tube had damaged while in use, however, no pieces/fragments were released from the shaver blade itself.The procedure was successfully completed using a back-up device.There was a surgical delay less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
Result of investigation: a device deficiency was not identified, and the root cause of the reported events could not be determined since the device was not returned for evaluation.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.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.

• 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: 19298348
• Report Number: 1219602-2024-00994
• Device Sequence Number: 12483460
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 06/07/2024; 08/06/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/14/2024; 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