MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HELICUT; HELICUT TM BLADE

Catalog Number 7205727

Device Problems Loose or Intermittent Connection (1371); Metal Shedding Debris (1804); Mechanical Jam (2983)

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

Event Date 05/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During shoulder sub-acromial decompression procedure when the surgeon used the burr, there were metal shavings noted.The surgeon experienced seizing of the device and shedding was observed towards the end of the procedure.The position of the burr was flush, relative to the tissue.The bone was noted to be fairly hard.There were no anatomy or procedure exceptions, and it did not appear that more force was required on the device than typical.The debris was suctioned out, but it is unsure if the surgeon was able to remove all of the debris.There is no product to return for investigation purposes as the device used in the procedure was discarded by the facility.

Manufacturer Narrative

Evaluation of the device was not possible, as the device is not being returned.Review of the device history records were performed which confirmed no inconsistencies.There were no internal processing issues, which could have contributed to the nature of the complaint.Due to this fact we are unable to determine what may have caused the user to experience the reported incident.No further investigation is warranted at this time.

• Brand Name: HELICUT
• Type of Device: HELICUT TM BLADE
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4851518
• MDR Text Key: 16609414
• Report Number: 1219602-2015-00138
• 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: User Facility,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 7205727
• Device Lot Number: 50828996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2015
• Date Device Manufactured: 08/01/2014
• 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: 30 YR