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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during shoulder arthroscopy the incisor plus elite blade was oscillating.It is unknown if there was an available back up device or a significant delay during the procedure.No patient injury or other complications were reported.Results of the investigation have concluded that this unit had a "shedding, flaking" which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h3,h6: the reported 5.5 mm incisor plus elite blade, used in treatment, has been returned for evaluation.The blade was returned disassembled.Reassembly of the blades confirmed the reported complaint.The blades will not rotate.Evaluation of the inner and outer blades edgeform shows the distal teeth are bent and worn.This tooth wear appears to be caused by an impact with each other.All indications point to excessive lateral load applied during use.Per the device instructions for use¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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 boulevard; mansfield MA 02048
• MDR Report Key: 9702305
• Report Number: 1219602-2020-00206
• Device Sequence Number: 1810818
• Product Code: HAB
• UDI-Device Identifier: 03596010555687
• UDI-Public: 03596010555687
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/23/2020

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: 04/08/2024
• Device Model Number: 72200081
• Device Catalogue Number: 72200081
• Device Lot Number: 50798557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 02/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1