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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE LONG 4.5MM SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. INCISOR PLUS ELITE LONG 4.5MM SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72200414
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 07/22/2020
Event Type  Injury  
Event Description

It was reported that during a hip arthroscopy surgery, the incisor plus elite broke off inside the patient's anatomy. No delay was reported. It is unknown if there was a smith and nephew back-up device available to complete the surgery. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

 
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Brand NameINCISOR PLUS ELITE LONG 4.5MM
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 Key10397255
MDR Text Key202581117
Report Number1219602-2020-01235
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72200414
Device Catalogue Number72200414
Device LOT Number50823353
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/19/2019
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: 08/12/2020 Patient Sequence Number: 1
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