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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RFNA / 12 / 420 5 DEG BEND / STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC RFNA / 12 / 420 5 DEG BEND / STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.233.242S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Physical Asymmetry (4573)
Event Date 03/28/2021
Event Type  Injury  
Manufacturer Narrative
Additional procode: hwc. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that during an open reduction internal fixation (orif) of the right femur on (b)(6) 2021, the more standard start point for a new retrograde femoral nail (rfn) caused a mal reduction of femur fracture as the nail passed the fracture site; changed to antegrade femoral nail and the problem went away. The procedure was successfully completed with a ten (10) minute delay. This report is for a rfna nail. This is report 1 of 1 for (b)(4).
 
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Brand NameRFNA / 12 / 420 5 DEG BEND / STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11706681
MDR Text Key260220749
Report Number2939274-2021-02016
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201346
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.233.242S
Device Catalogue Number04.233.242S
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 Received03/28/2021
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/22/2021 Patient Sequence Number: 1
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