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

Model Number	7210976
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy procedure, the blade was used and made lots of metal debris in the joint.Pieces were successfully removed from the patient with grasper and shaver suction.Backup device was available to complete the procedure.No significant delay and no patient complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.Review of the product ifu found adequate warnings and precautions to prevent damage to the device during use.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found for single use only.This product is warranted to be free from defects in material and workmanship.Do not reuse.Do not allow the rotating portion of any blade or burr to touch any metallic object such as a cannula or arthroscope.Damage to both instruments is likely.Damage to the blade can range from a slight distortion or dulling of the blade edge to actual fracture of the tip in vivo.If such contact does occur, inspect the tip.If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately.A clinical review was conducted and found based on the information provided, all the pieces were successfully removed from the patient using a grasper and a shaver suction.In addition, it was reported a backup device was available to complete the procedure.Since there was no significant delay or patient complication reported, no further clinical assessment is warranted.A relationship, if any, between the subject device and the reported event could not be determined.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
• MDR Report Key: 10797287
• Report Number: 1219602-2020-01780
• Device Sequence Number: 14200313
• Product Code: HAB
• UDI-Device Identifier: 03596010532626
• UDI-Public: 03596010532626
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: 09/14/2024
• Device Model Number: 7210976
• Device Catalogue Number: 7210976
• Device Lot Number: 50828121
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention