MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE POWER-MINI DISP 2.9; SAW, POWERED, AND ACCESSORIES

Catalog Number	72201513
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during a cmc arthroscopy, the head/tip of the incisor plus blade came off inside the joint space of the patient.The broken piece was removed from the patient with arthroscopic grasper/forceps.The procedure was completed with a surgical delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found the device and next to it the head/tip.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no 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 could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the failure include rough handling or excessive force to the device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: INCISOR PLUS ELITE POWER-MINI DISP 2.9
• 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: 19533046
• Report Number: 1219602-2024-01283
• Device Sequence Number: 7606262
• Product Code: HAB
• UDI-Device Identifier: 03596010654458
• UDI-Public: 03596010654458
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 07/31/2024

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: 72201513
• Device Lot Number: 51209743
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2024
• 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