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

Model Number	72200414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that on literature review ¿hip arthroscopy with initial access to the peripheral compartment provides significant improvement in fai patients.¿; after surgery 8 patients had extensive chondral damage requiring conversion to total hip arthroplasty.Paper indicates that a smith&nephew incisor blade was used, however no malfunction was reported during use.".
Additional Manufacturer Narrative
Doi:10.1007/s00167-020-06380-z dantas, p., gonçalves, s., mascarenhas, v., camporese, a., & marin-peña, o.(2021).Hip arthroscopy with initial access to the peripheral compartment provides significant improvement in fai patients.Knee surgery, sports traumatology, arthroscopy, 29(5), 1453-1460.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include a failure of a concomitant device.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.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.A review of risk management files found that there was insufficient information to tie the reported complaint to specific line items within the risk file.A complaint history review found no similar reported events.The instructions for use was 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.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.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 LONG 4.5MM
• 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: 12447171
• Report Number: 1219602-2021-01915
• Device Sequence Number: 3516927
• Product Code: HAB
• UDI-Device Identifier: 03596010553850
• UDI-Public: 03596010553850
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 72200414
• Device Catalogue Number: 72200414
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 09/10/2021; 03/24/2022
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 09/10/2021; 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown