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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 Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Date 11/12/2019
Event Type  Injury  
Event Description
It was reported that at the end of a shoulder arthroscopy, it was noticed that the acromionizer appeared to leave a burn on the patient at the entry site of the burr. The procedure had already been completed without delay using the same device. No patient injury or other complications were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key9442958
MDR Text Key170010387
Report Number1219602-2019-01533
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number7205327
Device Catalogue Number7205327
Device Lot Number50819816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/10/2019 Patient Sequence Number: 1
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