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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TW DRL F/COLE RAD DRL 4.0 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. TW DRL F/COLE RAD DRL 4.0 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 110245
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/27/2020
Event Type  Injury  
Event Description
It was reported that during meta tan surgery, the twist drill for cole radiolucent drill 4. 0 wobbled, as same as the first one, and failed to drill the third screw hole. The procedure was finished with a change in surgical technique, without inserting/tightening the third screw. It is unknown if there was a surgical delay. The patient was not injured beyond what has already been described.
 
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Brand NameTW DRL F/COLE RAD DRL 4.0
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
sarah freestone
1450 brooks rd.
memphis, TN 38116
0447940038
MDR Report Key10434286
MDR Text Key203799714
Report Number1020279-2020-04106
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K122170
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 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number110245
Device Catalogue Number110245
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/20/2020 Patient Sequence Number: 1
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