MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED INCISOR BLADE,4.5(6BX); SAW, POWERED, AND ACCESSORIES

Model Number	7205332
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an elbow arthroscopy, the curved incisor blade snapped while resecting.The tip of the inner blade was stuck inside of the outer blade; outer blade appears to be intact from visual inspection.Another blade was used to finish the procedure after a 10 min delay.The patient was not harmed.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: one (single) 7205332 4.5mm boxed incisor blade was used for treatment and returned for evaluation.These are sold as a box of six devices.They are not intended to be sold individually.There was obvious damage observed.The inner blade component distal cutting tip was snapped from its shaft.There were rotational wear bands skived into the outer surface of the inner blade.This is aligned with excess pressure being applied to the blade.The situation causes metallic shavings, which then seize up the inner blade inside the outer blade component.Per 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.Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).¿ complaint history review indicated no similar allegations for the lot number reported.Dhr/batch/lot review did not indicate a condition or product/procedure failure that supported the allegation.No root cause related to the manufacturing of the device was established.No further investigation required at this time.

• Brand Name: BOXED INCISOR BLADE,4.5(6BX)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9351504
• Report Number: 1219602-2019-01465
• Device Sequence Number: 19372542
• Product Code: HAB
• UDI-Device Identifier: 03596010251602
• UDI-Public: 03596010251602
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

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: 05/08/2024
• Device Model Number: 7205332
• Device Catalogue Number: 7205332
• Device Lot Number: 50804507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1