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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACROMIONIZER,4.0 EP-1,DSPL BL SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. ACROMIONIZER,4.0 EP-1,DSPL BL SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205326
Device Problem Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
Due no product return, the complaint could not be confirmed. Definitive conclusions cannot be made without a device to evaluate. Accurate investigation and evaluation are not possible. The product met specifications upon release to distribution. No further actions pursued at this time. If relevant information becomes available to assist with evaluation, the complaint will certainly be revisited.
 
Event Description
It was reported that when using the device, the shaver hand piece was getting very hot. No patient injuries were reported.
 
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Brand NameACROMIONIZER,4.0 EP-1,DSPL BL
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
MDR Report Key7032692
MDR Text Key143843127
Report Number1219602-2017-01416
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7205326
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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