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

Catalog Number	72205109
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that two incisor plus blades failed in the same way.The devices broke at the tip of the inner lumen.It is unknown whether the event happened during surgery, if there was patient involvement and if there was a back-up device available or if there was a delay.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H2: additional information in b5.H11: corrected information in h6 (health effect - impact code).
Event or Problem Description
It was reported that during an unknown procedure, one incisor plus blade failed.The device stopped moving.When the scrub technician removed the inner lumen, the tip of the inner lumen broke.No broken piece fell inside the patient.It is unknown if there was a back-up device available or if there was a delay.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: 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 of the device is broken at the distal end of the flexible portion of the shaft with the distal cutter of the inner shaft stuck in the channel of the outer shaft.There is biological debris on the returned items.A functional evaluation could not be performed due to the device being damaged.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 was associated with unintended use of the device.Factors that could have contributed include an application of excessive force or contact with another source.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: 18440256
• Report Number: 1219602-2024-00020
• Device Sequence Number: 6959190
• Product Code: HAB
• UDI-Device Identifier: 00885556708903
• UDI-Public: 00885556708903
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2024

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: 51152424
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 02/21/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/17/2024; 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2023
• 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