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

Catalog Number	7205305
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy, a small piece of the inner blade chipped off in the patient.The pieces were removed from patient.A backup device was available to complete the procedure with no delay or patient injuries.
Additional Manufacturer Narrative
One 3.5mm full radius 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 extensive abrasion at the tip and corresponding abrasion on the id of the inner blade.The condition of the device indicates an excessive side load during use which resulted in the observed bending and shedding.Per the device 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¿.Based on the results of the product evaluation the potential root cause is related to user technique.Since no harm is being reported no further assessment is warranted.

• Brand Name: FULL RADIUS BLADE,3.5MM,DISP
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8194371
• Report Number: 1219602-2018-01780
• Device Sequence Number: 11353687
• Product Code: HAB
• UDI-Device Identifier: 03596010251336
• UDI-Public: 03596010251336
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

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: 08/12/2023
• Device Catalogue Number: 7205305
• Device Lot Number: 50752560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 12/24/2018
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1