MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE BLADE 5.5MM DSPL 6BX; SAW, POWERED, AND ACCESSORIES

Model Number	72200081
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an arthroscopic ligamentoplasty of the right knee, it was found that filings of the incisor blade were appearing in the joint.Following this finding, the surgeon stopped the arthroscopy and proceeded to an open arthrotomy of the knee in order to clean and remove all foreign bodies, this using syringes of water and compresses to clean up in large volumes and a suction cannula to evacuate and washing with betadine serum.After checking the blade, the surgeon found that there was friction between the blade and its sheath which caused wear in several areas of the blade body.Surgery was completed after a non-significant delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A visual inspection of the returned device found that it is not in its original packaging.The device is worn from use, and there are abrasions on the inner blade.The inner blade is slightly bent.There is debris on the device.A functional assessment of the device found that there was grinding between the inner and outer blade, creating friction when the device rotates.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, off-axis insertion of the device, lack of irrigation during use, or an impact event inconsistent with normal use.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Our clinical investigation concluded: it was communicated via e-mail that all foreign bodies were removed.It was noted that the patient is in recovery.Since no further harm is anticipated, no further clinical/medical assessment is warranted at this time.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.

• Brand Name: INCISOR PLUS ELITE BLADE 5.5MM DSPL 6BX
• 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: 14046044
• Report Number: 1219602-2022-00508
• Device Sequence Number: 11978197
• Product Code: HAB
• UDI-Device Identifier: 03596010555687
• UDI-Public: 03596010555687
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 72200081
• Device Catalogue Number: 72200081
• Device Lot Number: 50854331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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: Male
• Patient Weight: 97 KG