MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/; SAW, POWERED, AND ACCESSORIES

Model Number	72200095
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during an unknown procedure, when the incisor plus elite blade was activated, metal flakes made from the inner blade.The procedure was completed without delay using a back-up device.No patient injury or other 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
H10.H3, h6: the reported 3.5 incisor elite blade, used in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the inner blade shed material during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive side loading during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.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.Based on the limited information provided the root cause of the reported metal flakes could not be determined.It is unclear if the instructions for use were adhered to however, it does caution ¿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.The retained metal debris is neither bio-inert nor approved for implantation and it is unknown how much remains within the surgical site and also unknown if corrosion, micro-motion and/or migration of the retained metal debris will occur.The patient impact beyond the reported events cannot be determined.No further clinical/medical assessment is warranted at this time.
Additional Manufacturer Narrative
The reported 3.5 incisor plus elite blade, used in treatment, was returned for evaluation.Functional inspection confirmed the inner blade does not rotate freely within the outer blade, friction was felt in the unloaded condition.Visual assessment of the device showed the outer blade is bent.There are visual signs of material galling and debridement on the inner and outer blade surfaces confirming the reported shedding.The condition of the device indicates it was subjected to excessive side loading during use.Per the device instruction for use under precautions ¿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.Based solely on the product evaluation the root cause of the reported issue is likely due to a user vs procedural event.The instruction for use does caution that ¿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¿.The retained metal debris is neither bio-inert nor approved for implantation and it is unknown how much remains within the surgical site and also unknown if corrosion, micro-motion and/or migration of the retained metal debris will occur.The patient impact beyond the reported events cannot be determined.

• Brand Name: INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9583195
• Report Number: 1219602-2020-00082
• Device Sequence Number: 3244038
• Product Code: HAB
• UDI-Device Identifier: 03596010555694
• UDI-Public: 03596010555694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 04/21/2020

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: 01/06/2024
• Device Model Number: 72200095
• Device Catalogue Number: 72200095
• Device Lot Number: 50779887
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 02/27/2020; 04/20/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/02/2020; 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1