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

Catalog Number	72200095
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery the shaver blade expelled some metal debris upon activation, it was noticed a squeaky sound upon assessment.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.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One used 3.5mm incisor plus blades were 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 shows an abrasion and debridement at the first edge form tooth.There is a corresponding abrasion on the id of the outer blade tip.The blade is soiled with human matter.The condition of the device indicates is was subjected to excessive side loading resulting in the reported shedding.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¿.No root cause related to the manufacturing process can be established.Based on the product evaluation the condition of the device indicates it was subjected to excessive side loading which resulted in the reported shedding.The instruction for use 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 remains how much remains within the surgical site and also unknown if corrosion, micro-motion and/or migration of the retained metal debris is likely.The impact to the patient is potential of retained non-implantable metal debris, possible local irritation and/or discomfort, additional radiological imaging/exposure, and although not likely 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: 9281524
• Report Number: 1219602-2019-01379
• Device Sequence Number: 387784
• Product Code: HAB
• UDI-Device Identifier: 03596010555694
• UDI-Public: 03596010555694
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Report Date (Section B): 12/19/2019

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: 04/09/2024
• Device Catalogue Number: 72200095
• Device Lot Number: 50798766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1