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	02/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that surgeon stated the helicut burr shed metal more than usual.No patient injury was reported.
Additional Manufacturer Narrative
One single 7205727 helicut tm blade returned.These are sold as a box of six devices.They are not intended to be sold individually.The device is used.Complaint reports that the device was used for a ¿shoulder¿ procedure.Complaint indicated: ¿it was reported that surgeon stated the helicut burr shed metal more than usual.No patient injury was reported.¿ the device is in relatively good condition.It was visually confirmed that there are extremely light wear patches on the outermost edges of the spiral blade.There are very light rotational scratches present on the inner diameter of the outer blade.Spin test produces a faint metallic sound with rotations.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 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: 7307836
• Report Number: 1219602-2018-00278
• Device Sequence Number: 1741513
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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: 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: 03/05/2018
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR