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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 Connection Problem (2900)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2020
Event Type  malfunction  
Event Description
It was reported that the guide pin sleeve does not connect with the lag screw drill sleeve. It is unknown when the event occurred, if there was any delay, if there was a backup available and if there was any patient involved in the case.
 
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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 rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
1450 brooks road
memphis, TN 38116
MDR Report Key10785477
MDR Text Key214566014
Report Number1020279-2020-06121
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,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674532
Device Catalogue Number71674532
Device Lot Number16FM02960
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2016
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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