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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HUMERAL RULER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. HUMERAL RULER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71751126
Device Problems Crack (1135); Naturally Worn (2988)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2020
Event Type  malfunction  
Event Description
It was reported that during set up inspection the humeral ruler presented wear and tear. There is a crack forming on the screw on collar (black plastic piece). No delay and the same device was used. No injuries or other complications were reported at this time. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameHUMERAL RULER
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 rd.
memphis, TN 38116
5123913905
MDR Report Key10824449
MDR Text Key215885389
Report Number1020279-2020-06377
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71751126
Device Catalogue Number71751126
Device Lot Number09CCT0015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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