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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. SHORT HEXDRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71631068
Device Problems Fitting Problem (2183); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that a retaining rods of a short hexdriver are stripped. In addition, the retaining rods won't fit into hex driver. As this was noticed during set up, the procedure was performed, without any delay, using a s+n back-up device. Patient was not impacted.
 
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Brand NameSHORT HEXDRIVER
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 Key13142392
MDR Text Key283150823
Report Number1020279-2022-00010
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/06/2016
Device Model Number71631068
Device Catalogue Number71631068
Device Lot Number06GM01036
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received02/10/2022
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

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