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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HANDLE, UNIVERSAL ENDOFEMORAL AIMER; ACCESSORIES,ARTHROSCOPIC
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SMITH & NEPHEW, INC. HANDLE, UNIVERSAL ENDOFEMORAL AIMER; ACCESSORIES,ARTHROSCOPIC Back to Search Results
Catalog Number 72201732
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/29/2016
Event Type  malfunction  
Event Description
It was reported that during a cruciate ligament reconstruction the device stopped working.A competitive back-up device was used to complete the procedure.No reported patient injuries.No other complications were noted.
 
Manufacturer Narrative
A review of the device history record was performed which confirmed no inconsistencies.
 
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Brand Name
HANDLE, UNIVERSAL ENDOFEMORAL AIMER
Type of Device
ACCESSORIES,ARTHROSCOPIC
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
james gonzales
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key6017792
MDR Text Key57475909
Report Number1219602-2016-01179
Device Sequence Number1
Product Code NBH
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 company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72201732
Device Lot Number50546601
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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