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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 100 -S ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 100 -S ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.038.400S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Physical Asymmetry (4573)
Event Date 12/10/2021
Event Type  Injury  
Manufacturer Narrative
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 on (b)(6) 2021, the patient underwent revision surgery with a previously implanted proximal femoral nailing system (tfna) nail and helical blade. Postoperative x-ray from the original case shows tfna fenestrated helical blade posterior outside of tfna nail causing loss of reduction. During the revision surgery, the old helical blade was removed and a new helical blade was implanted successfully. Patient consequence reported. Concomitant devices reported: unknown tfna nail (part# unknown, lot# unknown, quantity 1), unknown nail distal locking screw (part# unknown, lot# unknown, quantity unknown), unknown tfna end cap (part# unknown, lot# unknown, quantity 1). This report is for one (1) tfna fenestrated helical blade 100 -s. This is report 1 of 1 for (b)(4).
 
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Brand NameTFNA FENESTRATED HELICAL BLADE 100 -S
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 Key13191302
MDR Text Key283401763
Report Number2939274-2022-00051
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.038.400S
Device Catalogue Number04.038.400S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/07/2022 Patient Sequence Number: 1
Treatment
UNK - END CAPS: TFNA; UNK - NAILS: TFNA; UNK - SCREWS: NAIL DISTAL LOCKING
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