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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROX STR HUMERAL NAIL 8/7 X 16 TRIGEN HUMERAL NAIL SYSTEM

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SMITH & NEPHEW, INC. PROX STR HUMERAL NAIL 8/7 X 16 TRIGEN HUMERAL NAIL SYSTEM Back to Search Results
Catalog Number 71760816
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/28/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) customer indicated that there is no product/device to be returned for investigation analysis.
 
Event Description
It was reported the surgeon left the nail inside the medullary space during a planned removal surgery. The guide bolt instrument was unable to attach to the nail for removal.
 
Manufacturer Narrative
The associated complaint device was not returned. The device remains implanted.
 
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Brand NamePROX STR HUMERAL NAIL 8/7 X 16
Type of DeviceTRIGEN HUMERAL NAIL SYSTEM
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
yagna angirish
1450 brooks rd
memphis, TN 38116
9013995009
MDR Report Key5818745
MDR Text Key50310823
Report Number1020279-2016-00567
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K032722
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71760816
Device Lot Number15DM13235
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 Received06/28/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/20/2015
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: 07/25/2016 Patient Sequence Number: 1
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