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	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ankle arthroscopy procedure, the device broken off inside the patient.However, the pieces were successfully removed from the patient.Backup device was available to complete the procedure.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: one 72201513 disposable 2.9mm power mini incisor plus elite blade used in treatment, was returned for evaluation.The blade is in reasonably good condition.There was a small flat spot on the tip of the outer blade.It spun freely.All teeth were intact and were sharp.There was no major damage noted.The allegation was not confirmed.There was no loose material or absence of material.There was mention of a back up device used.No root cause related to the manufacture of the device was confirmed.

• 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 boulevard; mansfield MA 02048
• MDR Report Key: 9748366
• Report Number: 1219602-2020-00399
• Device Sequence Number: 19157458
• Product Code: HAB
• UDI-Device Identifier: 03596010654458
• UDI-Public: 03596010654458
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2022
• Device Model Number: 72201513
• Device Catalogue Number: 72201513
• Device Lot Number: 50838045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1