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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 Material Twisted/Bent (2981); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2022
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: case(b)(4).
 
Event Description
It was reported that, during an internal fixation surgery, the short hexdriver internal capture was bent and stuck. Surgery was resumed, without any delay, with a back-up device. Patient was not harmed. No further complications reported.
 
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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 Key14192401
MDR Text Key289958392
Report Number1020279-2022-01949
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71631068
Device Catalogue Number71631068
Device Lot Number20DM17894
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2020
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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