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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. SCREW, CORTICAL PLATE, FIXATION, BONE

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ARTHREX, INC. SCREW, CORTICAL PLATE, FIXATION, BONE Back to Search Results
Catalog Number AR-13380-36
Device Problem Device Damaged by Another Device (2915)
Patient Problem Bone Fracture(s) (1870)
Event Date 07/05/2017
Event Type  Injury  
Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided. No further patient information was provided at the time of this report or made available in response to follow-up communication. No additional adverse consequences have been reported from this event. This device is used for treatment. This is one of four submissions from the same event. The others are (b)(4). Device history record review revealed nothing relevant to this event. The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified. The cause of the event could not be determined from the information available and without device evaluation. This is the first complaint of this type for this part/lot combination. The potential cause(s) of this event will be communicated to the event reporter. If additional relevant information is received, a follow-up report will be submitted.
 
Event Description
It was reported that the first screw ((b)(4)) caused a vertical fracture of the femur. A total of 7 screws were used; the fracture got longer with each screw. The case was finished and cerclage wire was used to hold the femur together. Femoral osteotomy. No additional hospitalization was needed. Follow-up investigation: it was reported that during a femoral osteotomy case the contourlock femoral osteo small right plate, ar-13110r-01 ((b)(4)) was used. When implanting the first cortical screw, ar-13380-54 ((b)(4)) in the most distal of the proximal holes the femur began to fracture. The fracture continued as the screws were implanted distal to proximal. The screws were implanted as follows: ar-13380-50 ((b)(4)), ar-13380-46 ((b)(4)) and ar-13380-36 ((b)(4)). The case was completed using another manufacture's 18 gauge wire (qty. 2) to secure the fracture in cerclage technique. At this time the patient has not had a post op recheck. Patient is male, (b)(6). No additional hospitalization was needed.
 
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Brand NameSCREW, CORTICAL
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath, sr mdr analyst
1370 creekside boulevard
naples, FL 34108-1945
8009337001
MDR Report Key6725313
MDR Text Key80458025
Report Number1220246-2017-00273
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/01/2021
Device Catalogue NumberAR-13380-36
Device Lot Number10046139
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2016
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: 07/19/2017 Patient Sequence Number: 1
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