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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 72200730
Device Problem Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2018
Event Type  malfunction  
Event Description
It was reported that it takes a lot of effort for the bonecutter to take some of the bone. The bonecutter blade produced small chips of metal in the joint. They were removed by flushing out. A backup device was available to complete the procedure with no significant delay or patient injuries.
 
Manufacturer Narrative
The reported 4. 0mm elite acromionizer burr, intended for use in treatment, was not returned for evaluation. A relationship between the product and reported incident cannot be established as the product was not returned. Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed. From the information provided, the burr shed during use, causing metal debris to enter the joint space. An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly. The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality. There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
 
Manufacturer Narrative
Additional information in: expiration date: (b)(4) 2023 device manufacture date: (b)(4) 2018 correction catalog number: (b)(4) unique identifier (udi) #:(b)(4).
 
Manufacturer Narrative
Additional information. Date of the event is unknown.
 
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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 Key8128897
MDR Text Key129437277
Report Number1219602-2018-01638
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200730
Device Lot Number50724394
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2018
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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