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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE 4.5 BONECUTTER FR 180MM LG DSP SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. BLADE 4.5 BONECUTTER FR 180MM LG DSP SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7210979
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 09/02/2020
Event Type  Injury  
Event Description
It was reported that during a left hip arthroscopy with gluteus medius repair surgery, the bonecutter was locked and started overheating. The physician placed the shaver in the patient's abdomen. Then post-op drapes were removed and a burn could be noticed at the left side of the abdomen. Silvadene and telfa was placed on the wound. The procedure was successfully completed without delay using the same device. The patient was transferred to pacu. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameBLADE 4.5 BONECUTTER FR 180MM LG DSP
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 Key10590245
MDR Text Key208724698
Report Number1219602-2020-01479
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 User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7210979
Device Catalogue Number7210979
Device Lot Number50871404
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2020
Is the Reporter a Health Professional? No
Date Manufacturer Received11/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2020
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: 09/25/2020 Patient Sequence Number: 1
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