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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR,5.5MM ABRADER,180MML DISPOSABLE (3 SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. BURR,5.5MM ABRADER,180MML DISPOSABLE (3 SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200082
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
Event Date 11/26/2018
Event Type  Injury  
Event Description

It was reported that after a femoral osteoplasty, the patient removed the bandages and found what appeared to be a burn/blister. The patient went to the clinic and the surgeon thought there was potential that the shaft of the arthroscopy burr and or handpiece getting warm and coming in contact with the patient¿s skin, could have caused it while he was performing the femoral osteoplasty. 2 cm posterior to the inferior surgical incision on the lateral hip there is a 3 cm fluid filled blister. Surgery revision was not performed. Attempts were made to retrieve further information but no response was received from the complainant.

 
Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation. Thus, the complaint could not be verified and a root cause could not be determined with confidence. It is difficult to perform an accurate evaluation of a failure without having the failed product. As such the complaint is being closed without conclusion. However, if the product is returned in the future the complaint can be reopened and evaluated.

 
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Brand NameBURR,5.5MM ABRADER,180MML DISPOSABLE (3
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
5123585706
MDR Report Key8251533
MDR Text Key133202684
Report Number1219602-2019-00083
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 04/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72200082
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 01/15/2019 Patient Sequence Number: 1
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