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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 30MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 30MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71645030
Device Problem Device Damaged by Another Device (2915)
Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2020
Event Type  Injury  
Event Description
It was reported that during surgery when instruments where inside the patient, the mating part on t-handle broke while inserting screw using the medium hexdriver. Then the t-handle was changed to a t-handle universal chuck. The screw was inserted, but the threaded end on the inner rod of medium hexdriver broke. The piece remained inside the screw thread. Therefore, the trigen low profile screw 5. 0mm x 30mm was removed using a power tool from the hospital. A different size screw (5. 0mm×32. 5mm) was opened and inserted somehow using the broken t-handle and the long hexdriver. There was a 20 min delay.
 
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Brand NameTRIGEN LOW PROFILE SCREW 5.0MM X 30MM
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
0447940038
MDR Report Key10191786
MDR Text Key196314370
Report Number1020279-2020-02702
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111025
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 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71645030
Device Lot Number20BM18088
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/24/2020 Patient Sequence Number: 1
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