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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 AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - END CAPS: RAFN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non-union Bone Fracture (2369); Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - end caps: rafn/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, the patient underwent an antegrade intramedullary procedure for a closed displaced comminuted fracture of shaft of right femur. Infection was reported and revision of open treatment femoral fracture with internal fixation was performed. The distal incisions was opened and the distal interlock screws were removed. De-rotation was attempted through the foot, but the entire leg was rotating and a schanz pin was inserted proximally to hold the proximal segment stable while rotating the distal segment. The distal segment was rotated until the rotation matched the left leg and a new distal interlocking screw was placed. The wounds were irrigated and closed. Patient was re-operated after (41) days for post index bulletectomy and i&d. Repair of right femur with compression technique, and removal of hardware from right femur the distal locking screw was replaced with 2 new distal locking screws. Malalignment/malrotation was reported. This report is for (1) unk - end caps: rafn. This is report 5 of 5 for complaint (b)(4).
 
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Brand NameUNK - END CAPS: 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 Key12453911
MDR Text Key271005451
Report Number2939274-2021-05310
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 study
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2021
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 Received08/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/10/2021 Patient Sequence Number: 1
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