MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE BL 4.5MM DSPL DYO PW; SAW, POWERED, AND ACCESSORIES

Catalog Number	7210976
Medical Device Problem Codes	Break (1069); Flaked (1246)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that during a knee arthroscopy, small pieces of the incisor plus elite went into the patient´s knee.The procedure was completed with a s+n back up device.There was a non-significant surgical delay and no further complications were reported.
Additional Manufacturer Narrative
B5 was updated.H3, h6: a device deficiency was not identified, and the root cause of the reported event 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.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 there were no clinical factors found which would have contributed to the reported retained fragments of the blade.The incisor plus elite blade is an external communicating device that is neither manufactured nor intended for implantation and should have limited tissue/bone contact as long-term implantation data is not available.The patient impact beyond the retained blade fragments and surgical delay could not be definitely concluded.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Event or Problem Description
It was reported that during a knee arthroscopy, small pieces of the incisor plus elite went into the patient´s knee.The very small fragments were left inside the body.The procedure was completed with a s+n back up device.There was a non-significant surgical delay and no further complications were reported.
Additional Manufacturer Narrative
H11: corrected information in h6 (medical device problem code).
Additional Manufacturer Narrative
H3, h6: a device deficiency was not identified, and the root cause of the reported event 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.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 there were no clinical factors found which would have contributed to the reported retained fragments of the blade.The incisor plus elite blade is an external communicating device that is neither manufactured nor intended for implantation and should have limited tissue/bone contact as long-term implantation data is not available.The patient impact beyond the retained blade fragments and surgical delay could not be definitely concluded.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: INCISOR PLUS ELITE BL 4.5MM DSPL DYO PW
• 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: 17890106
• Report Number: 1219602-2023-01936
• Device Sequence Number: 15285603
• Product Code: HAB
• UDI-Device Identifier: 03596010532626
• UDI-Public: 03596010532626
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup
• Report Date (Section B): 12/22/2023

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 Catalogue Number: 7210976
• Device Lot Number: 51119672
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: 11/17/2023; 11/17/2023; 12/19/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/22/2023; 11/22/2023; 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown