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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - END CAPS: RAFN ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - END CAPS: RAFN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Thrombosis (2100); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown rafn end cap/ unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. (b)(4). 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 on an unknown date, the patient was implanted with an expert retrograde/ antegrade femoral nail to treat a femoral shaft fracture. Approximately 73 days after implantation, it was confirmed that there was a bone union. The post operative complication presented was deep vein thrombosis (dvt). Patient outcome is unknown. No further information is available. This report is for unknown rafn end cap. This is report 2 of 4 for (b)(4).
 
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Brand NameUNK - END CAPS: RAFN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10446055
MDR Text Key204214275
Report Number2939274-2020-03764
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received08/18/2020
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: 08/24/2020 Patient Sequence Number: 1
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