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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 5.5 ABRADER 180 LG HIGH VIS DSPL. SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. BURR 5.5 ABRADER 180 LG HIGH VIS DSPL. SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72203127
Device Problem Material Integrity Problem (2978)
Patient Problem Injury (2348)
Event Date 06/06/2020
Event Type  Injury  
Event Description
It was reported that during surgery, the blue plastic part in the distal part of the burr 5. 5 abrader seems worn out by the rotation of the stem in the part of the graft, leaving blue whips in the joint and on a gauze. It is unknown whether there was a back up available or delay in the case. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameBURR 5.5 ABRADER 180 LG HIGH VIS DSPL.
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10262222
MDR Text Key198494298
Report Number1219602-2020-01019
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2020
Device Model Number72203127
Device Catalogue Number72203127
Device Lot Number50735557
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/14/2018
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: 07/12/2020 Patient Sequence Number: 1
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