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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HFN 11.5MMX25CM LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. HFN 11.5MMX25CM LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71701125L
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Injury (2348); No Information (3190)
Event Date 05/31/2017
Event Type  Injury  
Manufacturer Narrative
The associated complaint devices were not returned for evaluation. Please see attached for our investigation summary. (b)(4).
 
Event Description
It was reported the distal screws backed out of the nail and had to be removed. The nail remains implanted.
 
Event Description
It was reported both distal screws backed out of the nail and had to be removed on 2 different occasions.
 
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Brand NameHFN 11.5MMX25CM LEFT
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
MDR Report Key6675312
MDR Text Key107249630
Report Number1020279-2017-00486
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K043052
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 10/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/11/2022
Device Model Number71701125L
Device Catalogue Number71701125L
Device Lot Number12DM07770
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 Received05/31/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/13/2012
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: 06/28/2017 Patient Sequence Number: 1
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