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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 3.2MM GUIIDE PIN SLEEVE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. INTERTAN 3.2MM GUIIDE PIN SLEEVE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674532
Device Problem Failure to Align (2522)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2020
Event Type  malfunction  
Event Description
It was reported that the alignment is off on the intertan 3. 2mm guide pin sleeve and needs to be replaced. The procedure was completed with standard instruments. No harm or injury was reported.
 
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Brand NameINTERTAN 3.2MM GUIIDE PIN SLEEVE
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
sarah freestone
1450 brooks road
memphis, TN 38116
MDR Report Key10014591
MDR Text Key189570820
Report Number1020279-2020-01415
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674532
Device Catalogue Number71674532
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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