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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 4.7MM X 40MM OST SCR PT PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. EVOS 4.7MM X 40MM OST SCR PT PLATE, FIXATION, BONE Back to Search Results
Model Number 72434740
Device Problem Difficult to Insert (1316)
Patient Problems Bone Fracture(s) (1870); Bone Shedding Debris (4557)
Event Date 06/16/2021
Event Type  Injury  
Event Description

It was reported that, during an internal fixation, a evos 4. 7mm x 40mm osteopenia screw partially threaded (case-(b)(4)) and a evos 4. 7mm x 42mm osteopenia screw partially threaded (case-(b)(4)) were not suitable to fix all medial malleolus fractures and destroyed the smaller fragments of the bone. He states that the thread is difficult to start because it is not self tapping, and that he preferred the old sized 4. 0mm cancellous screws from our previous orif set tc-100. Surgery was resumed, after a non-significant delay, with a back-up device. Current state of the patient is unknown.

 
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Brand NameEVOS 4.7MM X 40MM OST SCR PT
Type of DevicePLATE, FIXATION, BONE
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 Key12101214
MDR Text Key259433345
Report Number1020279-2021-05598
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK172262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72434740
Device Catalogue Number72434740
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
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: 07/01/2021 Patient Sequence Number: 1
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