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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
Model Number 72200724
Device Problems Break (1069); Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/29/2019
Event Type  Malfunction  
Manufacturer Narrative

The device is currently under investigation by the manufacturing site.

 
Event Description

It was reported that during a bone block surgery, while using the burr and hub, they snapped off into two pieces after being used for under 1 minute, the device did not break inside the patient and there was no shedding or flaking due to this malfunction. The procedure was completed with a back up device with no significant delay or patient injury reported. Preliminary results of investigation have concluded that this unit overheated due to an inadequate irrigation flow which makes it a reportable event. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

 
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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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10643606
MDR Text Key210246568
Report Number1219602-2020-01531
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/13/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/07/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72200724
Device Catalogue Number72200724
Device LOT Number50801990
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/31/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/25/2019
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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