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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 Problems Difficult to Remove (1528); Metal Shedding Debris (1804)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/13/2015
Event Type  Malfunction  
Manufacturer Narrative

Initial reporter: international phone number (b)(46). Devices have not been returned for evaluation. The investigation was limited to the information provided. The investigation could not draw any conclusions about the reported event. Should the devices be received, the investigation will be reopened. (b)(4).

 
Event Description

It was reported that during a shoulder arthroscopy procedure using acromionizer, 4. 0 ep-1, dspl bl metallic residues were visible. The site was flushed/irrigated but it was noted that some debris remained in situ. There was a minimal procedural delay encountered. The procedure was completed using a back-up device. This incident did not result in any patient injury or complications.

 
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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
james gonzales
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key5063254
MDR Text Key25922523
Report Number1219602-2015-00957
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/13/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2019
Device Catalogue Number7205326
Device LOT Number50802884
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 Received04/13/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/01/2014
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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