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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown tfna helical blade/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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 on (b)(6) 2020, a revision surgery occurred due to nonunion and malunion. There were no reported device malfunctions. Some hardware was removed including removal of 2x 5. 0mm distal interlock screws, which were locked into a trochanteric fixation nail advanced (tfna) nail and helical blade construct. Screws were removed so traction could be performed, and proper reduction or compression could take place in the proximal portion of femur where the nonunion and malunion occurred. New 5. 0mm distal interlock screws put in place. There was no surgical delay. The screws were removed easily without intervention. There was a less than desirable outcome due to nonunion and malunion in femoral neck and subtrochanteric fracture with delayed healing present. Procedure was successfully completed. This is report 4 of 4 for (b)(4). This report is for an unknown tfna helical blade.
 
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Brand NameUNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
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 Key10648687
MDR Text Key210590405
Report Number2939274-2020-04575
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
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 Received10/16/2020
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: 10/08/2020 Patient Sequence Number: 1
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