MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 4.0MM ELITE ACROMIONIZER BURR(6); SAW, POWERED, AND ACCESSORIES

Catalog Number 72200724

Device Problems Break (1069); Melted (1385); Overheating of Device (1437); Difficult to Remove (1528)

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

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

One 72200724 dyonics 4.0mm elite acromionizer burr blade device returned.The product has become over heated and the sluff chamber and adapter body have begun to melt.Noisy/grinding and overheating/melted material condition has been found to be consistent with the device being tested/run without or with inadequate suction/irrigation.This device is not intended to be engaged without suction either.Irreversible damage may occur to blades or burrs if they are run without the flow of irrigation (dry).This can cause bone or tissue fragments to not be excised efficiently.Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Root cause related to the manufacture of the device was not confirmed.

Event Description

It was reported that the customer couldn't remove the inner shaft from outer shaft due to the connection part of the blade was broken.The procedure was completed with the back-up device.No patient injuries and complication were reported.According to product evaluation results, the device has become over heated and the sluff chamber and adapter body have begun to melt.

• Brand Name: DYONICS 4.0MM ELITE ACROMIONIZER BURR(6)
• 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 ; 5123585706
• MDR Report Key: 7898983
• MDR Text Key: 121453737
• Report Number: 1219602-2018-01307
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2022
• Device Catalogue Number: 72200724
• Device Lot Number: 50666042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2017
• 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