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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACROMIONIZER,5.5,EP-1,DSPL BL(6) SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. ACROMIONIZER,5.5,EP-1,DSPL BL(6) SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205327
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2017
Event Type  malfunction  
Event Description
It was reported that the burr rubs against the sheath. All fragments were removed from the patient. No patient injury was reported. There was no significant delay and back up was available to complete the procedure.
 
Manufacturer Narrative
One 5. 5 acromionizer burr was returned for evaluation. Visual assessment of the device identified a contact point on a section of the outer sheath at its distal end. The bronze bushing shows a contact point corresponding with the contact point on the sheath. Functional inspection was performed and the inner blade rotated freely within the outer blade, no friction was felt in the unloaded condition.
 
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Brand NameACROMIONIZER,5.5,EP-1,DSPL BL(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
MDR Report Key7580850
MDR Text Key110677240
Report Number1219602-2018-00711
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeFR
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 06/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7205327
Device Catalogue Number7205327
Device Lot Number50659783
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2017
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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