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

Catalog Number	72200081
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery the knife does not work properly because of a difficult rotation of the knife, this caused that the knife head release heat (overheating, an error message : knife block seen).No patient injury or other complications were reported.Procedure was completed using the same device.
Additional Manufacturer Narrative
Updated information.One 5.5mm incisor plus elite blade was returned for evaluation.Functional inspection was performed and the inner blade did not rotate freely within the outer blade, friction was felt in the unloaded condition.The blade is bent.The inner blade showed a slight abrasion at the distal tip and damage to the edgeform teeth.The outer blade also showed a slight abrasion and damage to the edgeform teeth.The condition of the device indicates it was subjected to an excessive side load during use.Per the devices 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¿.No root cause related to the manufacture of the device can be established.Corrected information.
Event or Problem Description
It was reported that, during an unspecified surgery the knife would not work properly because of a difficult rotation of the knife; this caused that the knife head released heat (overheating, an error message : knife block seen).Procedure was completed using the same device.No patient injury or other complications were reported.

• 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: 8242083
• Report Number: 1219602-2019-00063
• Device Sequence Number: 2082326
• Product Code: HAB
• UDI-Device Identifier: 03596010555687
• UDI-Public: 03596010555687
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2019

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: 05/01/2022
• Device Catalogue Number: 72200081
• Device Lot Number: 50661732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 01/28/2019; 01/28/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 01/29/2019; 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1