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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. DYONICS 4.0MM ELITE ACROMIONIZER BURR(6) SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200724
Device Problems Break (1069); Melted (1385); Overheating of Device (1437); Difficult to Remove (1528); Knife (3156)
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.

 
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Brand NameDYONICS 4.0MM ELITE ACROMIONIZER BURR(6)
Type of DeviceSAW, 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 Key7898983
MDR Text Key121453737
Report Number1219602-2018-01307
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 09/20/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/21/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72200724
Device LOT Number50666042
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/04/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/23/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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