MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE 3.5MM DISP; SAW, POWERED, AND ACCESSORIES

Catalog Number 7205305

Device Problem Degraded (1153)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the full radius blade was rusted.No case reported´therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3,h6: the reported 3.5 full radius blade, intended for use 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 blade was rusted.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: tarnish being mistaken for rust.Sliver plating is a smith+nephew process used at the time of manufacture of these blades to improve lubricity and allow for friction free contact between the stainless steel inner and outer blades.The appearance of the "tarnish" and discoloration does not have any adverse effect on the performance of the device, procedure or patient.The tarnishing discoloration is a cosmetic issue only.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 complaint records was performed for the reported device, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: FULL RADIUS BLADE 3.5MM DISP
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10151368
• MDR Text Key: 195385628
• Report Number: 1219602-2020-00899
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2024
• Device Catalogue Number: 7205305
• Device Lot Number: 50803598
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/20/2020
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/13/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention