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

Model Number 7205727

Device Problem Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2018

Event Type  malfunction  

Event Description

It was reported that surgeon stated the helicut burr shed metal more than usual.No patient injury was reported.

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)
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7307836
• MDR Text Key: 101490977
• Report Number: 1219602-2018-00278
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010404664
• UDI-Public: (01)03596010404664(17)220403(10)50656703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR