• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. DYONICS 4.0MM ELITE ACROMIONIZER BURR(6) SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200730
Device Problem Material Disintegration (1177)
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
Date of the event is unknown.
 
Manufacturer Narrative
Additional information in: expiration date: (b)(4) 2023 device manufacture date: (b)(4) 2018 correction. Catalog number: 72200730 unique identifier (udi) #: (b)(4).
 
Manufacturer Narrative
One 72200730 dyonics 4. 0mm acromioblaster burr product reported on. The complaint states: ¿it was reported that it takes a lot of effort for the bone cutter to take some of the bone. The bone cutter 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. ¿ the product was not returned for evaluation. Due to product unavailability, the complaint could not be ultimately confirmed. Definitive conclusions, accurate investigation and evaluation were not fully possible without evaluation of physical product. Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition. Shedding material condition has been found to be consistent with the device having inadvertent pressure applied while deburring which causes wear bands on the inner blade surface. The symptom points to excessive lateral load during use causing a mis-alignment of the inner and outer blade resulting in the shedding. 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. Final product met predetermined specifications upon release to distribution. No patient harm or injury is being reported as a result of this device related incident, and all of the metal debris was flushed out. There is no indication of adverse patient consequence as a result. No further clinical assessment is warranted based on the information provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8129019
MDR Text Key129327548
Report Number1219602-2018-01639
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 03/21/2019
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 Number50718389
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 Received03/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-