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

Catalog Number 7205727

Device Problems Break (1069); Detachment Of Device Component (1104); Dull, Blunt (2407)

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

Event Date 02/15/2013

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated for the source of metal particulate.The inside of the outer edge form was observed to have some wear present, caused by rubbing of the inner blade.A measurement for tir was conducted on the outer blade and it was observed that the blade tir was excessive at.0224, which equates to a bend of approximately.005.The bend in the blade was found to exceed design tolerance.A blade bent in this fashion is typically induced through excessive leverage during use.A review of the device history record was performed which confirmed no inconsistencies.After the evaluation the root cause was determined to be user error.No further investigation is necessary at this time.(b)(4).

Event Description

During a shoulder arthroscopy procedure it was reported that the blade was dull when resecting distal clavicle and small shreds of metal from the blade came off.The shreds were removed by the regular shaver.A back-up device was available and the surgery was completed successfully.A five to ten minute delay was experienced and no patient injury was reported.

• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4973546
• MDR Text Key: 23852840
• Report Number: 1219602-2015-00715
• 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: company representative
• Reporter Occupation: Health Professional
• Report Date: 03/01/2013

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 Expiration Date: 07/31/2017
• Device Catalogue Number: 7205727
• Device Lot Number: 50676887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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