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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTI ROTATION BAR ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. ANTI ROTATION BAR ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674041
Device Problems Failure to Align (2522); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2022
Event Type  malfunction  
Event Description
It was reported that, during trauma case, the anti rotation bar was bent and therefore throwing off alignment of drills and screws. Procedure was resumed, without any delay, with a back-up device. No patient complications were reported.
 
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
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Brand NameANTI ROTATION BAR
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 Key13777939
MDR Text Key287923098
Report Number1020279-2022-01194
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 Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674041
Device Catalogue Number71674041
Device Lot Number14KSP0007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/09/2015
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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