MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HELICUT TM BLADE (6/BOX); SAW, POWERED, AND ACCESSORIES

Catalog Number	7205727
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a procedure, metal flakes were shed when trying to resect an osteophyte (bone spur).It is unknown whether there was a back-up device available to complete the intended procedure.Even though it remains unknown if the flakes were removed from the patient, it was stated that neither patient injuries/complications nor delay surgical time happened in this case.
Additional Manufacturer Narrative
One 7205727 helicut blade returned.These are sold in a 6 pack box.This lot was manufactured in 2014 in (b)(4).As of (b)(4) 2016, the manufacturing of these devices was transferred from (b)(4) to smith and nephew (b)(4).Not intended to be sold individually.There was no shedding observed upon receipt.There was no shedding observed after testing.Please note: shedding has been found to be consistent with wear bands created from inadvertent excess side loading pressure being applied to the device.No root cause related to the manufacture of the device was confirmed.

• Brand Name: HELICUT TM BLADE (6/BOX)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8158088
• Report Number: 1219602-2018-01750
• Device Sequence Number: 2178362
• Product Code: HAB
• UDI-Device Identifier: 03596010404664
• UDI-Public: 03596010404664
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/15/2019

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: 11/30/2019
• Device Catalogue Number: 7205727
• Device Lot Number: 50850403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1