MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RAZORCUT BLADE,4.5 DISP,EP-1; SAW, POWERED, AND ACCESSORIES

Model Number	7205318
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported 4.5mm razorcut blades, used in treatment, have been returned for evaluation.A used and three unused devices were returned.Visual assessment of the used device showed visible signs of material galling and debridement on the blades.Functional inspection was performed and the inner blades did not rotate freely within the outer blades, friction was felt.The outer blades are bent.The unused devices were functionally inspected and the inner blades were found to rotate freely within the outer blades, no friction was felt in the unloaded condition.The condition of the used blade indicate they were subjected to an excessive lateral load during use.Per the devices instruction 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 complaint and manufacturing records was performed and there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Conclusion: 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 ¿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 material of the razorcut blade is 304 stainless steel which is an austenitic stainless steel alloy intended for surgical applications and is biologically compatible; however, this device is not approved for implantation.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of possibly retained non-implantable foreign body fragments cannot be determined.No further medical assessment can be rendered at this time.(b)(6).
Event or Problem Description
It was reported that, during an unknown procedure, a blade was opened and once it was mounted on the shaver it did not turn, the internal rotary of the blade struggled to turn inside the external metal cannula.Then, trying to turn it by hand was very difficult and did not have the usual smooth rotation.The procedure was completed with a backup device with no delay and no other complications were reported.Results of the investigation have concluded that this unit had signs of 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
The reported 4.5mm razorcut blades, used in treatment, have been returned for evaluation.Two used and three unused devices were returned.Visual assessment of the used devices showed visible signs of material galling and debridement on the blades.Functional inspection was performed and the inner blades did not rotate freely within the outer blades, friction was felt.The outer blades are bent.The unused devices were functionally inspected and the inner blades were found to rotate freely within the outer blades, no friction was felt in the unloaded condition.The condition of the used blades indicate they were subjected to an excessive lateral load during use.Per the devices ifu (b)(4) ¿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 complaint and manufacturing records was performed and there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.Conclusion: based solely on the product evaluation the root cause of the reported issue is likely due to a user vs procedural event.The ifu (b)(4) 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 material of the razorcut blade is 304 stainless steel which is an austenitic stainless steel alloy intended for surgical applications and is biologically compatible; however, this device is not approved for implantation.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of possibly retained non-implantable foreign body fragments cannot be determined.No further medical assessment can be rendered at this time.

• Brand Name: RAZORCUT BLADE,4.5 DISP,EP-1
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 10063863
• Report Number: 1219602-2020-00789
• Device Sequence Number: 3573982
• Product Code: HAB
• UDI-Device Identifier: 03596010251466
• UDI-Public: 03596010251466
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2023
• Device Model Number: 7205318
• Device Catalogue Number: 7205318
• Device Lot Number: 50741454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 05/17/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other