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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 Material Fragmentation (1261); 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 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 and no patient injuries.
 
Manufacturer Narrative
See c-(b)(4) eleven shelf cartons of product 72200724 (65 individual burrs; 10 cartons of 6 and one carton of were returned from lot 50741489. They are all new and unsealed. The product used in the procedure was not returned for evaluation. Definitive conclusions, accurate investigation and evaluation were not definitive without evaluation of physical product. If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will be revisited. Factors that may affect device performance include: device ability, surgical ability, procedure location, tissue condition and use per product recommendations. Influences that could compromise product performance or integrity that are unrelated to manufacture include: blade hand piece not fully loaded and or locked into mdu hand set. Incompatible force, torque or leverage applied. Unexpected bone density/condition. Change of approach during use. Insufficient irrigation or engaging the device without suction. Seizing of blades due to inadequate bio matter excision. Use not compliant with instructions for use, tech guides or specific procedure. Per instructions for use: ¿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. Make sure the hand piece is off while changing blade tip position. 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. Ensure that suction of 128 mmhg minimum is flowing while the instrument is running. Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry). ¿ final product met predetermined specs 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. Foreign zip code:(b)(4). Corrected.
 
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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 Key8100013
MDR Text Key128270422
Report Number1219602-2018-01607
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
Report Date 02/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200724
Device Lot Number50741489
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 Received02/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2018
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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