MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 5.5MM ELITE ACROMIOBLASTER BURR; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200731

Device Problems Overheating of Device (1437); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).No evaluation conducted to date, awaiting receipt of device.(b)(4).

Event Description

It was reported that during an sad procedure, the device made an audible noise and became hot to the point that the plastic fused.No patient injury or complications were reported.

Manufacturer Narrative

Visual assessment showed the polycarbonate components, the sluff chamber and adapter body are melted.Functional inspection was performed and the inner burrs rotated freely within the outer sheath as intended.The audible noise and melting was likely the result of not having adequate irrigation when operating the device.After the evaluation the root cause for the reported issue was determined to be user error.A review of the device history record was performed which confirmed no inconsistencies.

• Brand Name: DYONICS 5.5MM ELITE ACROMIOBLASTER BURR
• 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: 5906753
• MDR Text Key: 53112194
• Report Number: 1219602-2016-00528
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 72200731
• Device Lot Number: 50979264
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• 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