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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULATED IMPACTOR- MED ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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SMITH & NEPHEW, INC. CANNULATED IMPACTOR- MED ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71675081
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/10/2021
Event Type  malfunction  
Event Description
It was reported that after procedure, it was found that the cannulated impactor - short and the cannulated impactor- med were fused together and will not come apart. No patient injury or other complications were reported.
 
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Brand NameCANNULATED IMPACTOR- MED
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
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11784558
Report Number1020279-2021-03839
Device Sequence Number1
Product Code HSB
UDI-Device Identifier03596010648600
UDI-Public03596010648600
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71675081
Device Catalogue Number71675081
Device Lot Number16EM02155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage
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