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

Model Number	7205727
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the helicut burr was shedding and some debris became stuck in the tissue.No delay or patient injury was reported.
Additional Manufacturer Narrative
Complaint observation indicated shedding as reason for return.The device is in relatively good condition.It was visually confirmed that there are score rings present on the inner diameter of the outer blade.This has been identified as a source of light surface material shedding.There are also small dings at various spiral blade edge locations.The cause of the scoring and dings are aligned with inadvertent contact with hard surface such as bone and bone chip excision during use.No root cause related to the manufacturing of the device was established.

• 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: 6905435
• Report Number: 1219602-2017-01221
• Device Sequence Number: 16172044
• Product Code: HAB
• UDI-Device Identifier: 03596010404664
• UDI-Public: (01)03596010404664(17)220403(10)50656703
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2017

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: 04/03/2022
• Device Model Number: 7205727
• Device Catalogue Number: 7205727
• Device Lot Number: 50656703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1