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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: RAFN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: RAFN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Malunion of Bone (4529)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown rafn construct/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a synthes employee. 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
This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing surgical repair of a distal femur or femoral shaft fractures. Failed surgical repair of a distal femur or femoral shaft fractures has been identified as the reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: 10 patients had subsequent surgery within 90 days after index surgery. 14 patients had nonunion within 90 days after index surgery. 38 patients had subsequent surgery within 12 months after index surgery. 48 patients had nonunion within 12 months after index surgery. 1 patient had malunion within 90 days after index surgery. 4 patients had malunion within 12 months after index surgery. This report is for an expert retrograde/antegrade femoral nail (r/afn). This is report 4 of 4 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: RAFN
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 Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12303366
MDR Text Key266047150
Report Number2939274-2021-04578
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,study
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
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 Received08/03/2020
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: 08/10/2021 Patient Sequence Number: 1
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