MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE,EP-1 LONG,; SAW, POWERED, AND ACCESSORIES

Model Number	7205341
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon use the product left metal shavings in the joint of the patient.
Additional Manufacturer Narrative
One 7205341 long ep-1 full radius blade returned.Per the complaint, this device was used for a hip arthroscopy procedure and said: ¿upon use the product left metal shavings in the joint of the patient¿.The device is less than one year old.The outer diameter of the inner blade surface has substantial skiving damage; wear band.This surface condition indicates excessive force was applied to the devices.The overall length of the blade is bowed.Per ifu: ¿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 blade¿.No root cause related to the manufacture of the device can be established.

• Brand Name: FULL RADIUS BLADE,EP-1 LONG,
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7187916
• Report Number: 1219602-2018-00069
• Device Sequence Number: 63543
• Product Code: HAB
• UDI-Device Identifier: 03596010251664
• UDI-Public: (01)03596010251664(17)191209(10)50668709
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 02/01/2018

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: 06/09/2019
• Device Model Number: 7205341
• Device Catalogue Number: 7205341
• Device Lot Number: 50668709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1