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

Catalog Number 7205727

Device Problem Material Disintegration (1177)

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

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

Awaiting receipt of device.

Event Description

It was reported shedding.

Manufacturer Narrative

Two unopened helicut blades were returned for evaluation.The devices in question were not returned for examination prohibiting confirmation of the reported shedding.Functional and dimensional inspection of the devices confirmed they met design requirements.A review of the manufacturing records was performed which confirmed no abnormalities were reported with this lot during manufacture.A complaint history review identified no additional complaints for this manufactured lot.Without the return of the devices in question a root cause cannot be determined.Further investigation is not warranted at this time.

• 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 w. william cannon; austin, TX 78735 ; 5123585706
• MDR Report Key: 6325616
• MDR Text Key: 67485667
• Report Number: 1219602-2017-00185
• Device Sequence Number: 1
• Product Code: HAB
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 7205727
• Device Lot Number: 50977900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 02/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1