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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA INTERFACE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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SMITH & NEPHEW, INC. TRAUMA INTERFACE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 71692802
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2021
Event Type  Injury  
Event Description
It was reported that, during meta-tibia nail application with sureshot procedure, sureshot interface was turned on and displayed error: crc check field. No patient injury, no delay, change in surgical technique were used to finish the procedure.
 
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Brand NameTRAUMA INTERFACE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
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
5123913905
MDR Report Key11689784
MDR Text Key246217590
Report Number1020279-2021-03215
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeTC
PMA/PMN Number
K170280
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 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71692802
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2021
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 Initial

Patient Treatment Data
Date Received: 04/19/2021 Patient Sequence Number: 1
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