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

Model Number	72201513
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that at the beginning of an arthroscopy procedure, the specialist entered the 2.9 motor terminal through the work port and it worked normally, later he changed the instrument in said port and when he wanted to use the incisor plus again it no longer worked, he requested to check the device and when disassembling it was found that the internal part of the device was fractured, unfortunately there was only one kit and there was no way to solve it, so they performed open surgery and visualized the joint sporadically with arthroscopy.The procedure was successfully completed with non-significant delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H2: additional information: b5: event description.
Event or Problem Description
It was reported that at the beginning of an arthroscopy procedure, the specialist entered the 2.9 motor terminal through the work port and it worked normally, later he changed the instrument in said port and when he wanted to use the incisor plus again it no longer worked, he requested to check the device and when disassembling it was found that the internal part of the device was fractured.It did broke inside, however, no parts were left inside the patient.Unfortunately there was only one kit and there was no way to solve it, so they performed open surgery and visualized the joint sporadically with arthroscopy.The procedure was successfully completed with non-significant delay.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.The inner blade shaft is fractured.The outer blade shaft is bent, this failure has been determined to be related to the reported event.A functional evaluation could not be performed due to the condition the device was returned in.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 no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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 review states that an undated photo of the device was provided for review and confirms a fractured device.Without the requested clinical information a thorough medical investigation cannot be rendered.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• 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: 16521898
• Report Number: 1219602-2023-00352
• Device Sequence Number: 14039198
• Product Code: HAB
• UDI-Device Identifier: 03596010654458
• UDI-Public: 03596010654458
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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): 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72201513
• Device Catalogue Number: 72201513
• Device Lot Number: 50998449
• 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: 02/18/2023
• Supplement Date Received by Manufacturer: 04/14/2023; 12/27/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/25/2023; 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 76 KG