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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
Model Number 7205326
Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2018
Event Type  Malfunction  
Event Description

It was reported that when the surgeon was used the new probe, a lot of metal debris fell off. The surgeon continued to use the affected product to continue the surgery, at last used a blade to clean up all the debris.

 
Manufacturer Narrative

Examination is not possible, as the device will not be returned. The investigation could not draw any conclusions about the reported event without the return of the device.

 
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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
5123585706
MDR Report Key7810108
MDR Text Key118236067
Report Number1219602-2018-01118
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/27/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number7205326
Device Catalogue Number7205326
Device LOT Number50673387
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/07/2017
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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