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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: TFNA ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: TFNA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown tfna nail/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
It was reported that on an unknown date, the patient had a subtrochanteric nonunion. An exchange was made with grafting after compressing and plating. Radiographic and clinic progress was looking great until she rebroke. The proximal screw, nail, and plate removal were performed without event. During the distal nail removal downward tapping, vice grip back-slapping, distal finger extraction, thin osteotomes, and breaking the hip revision vice-grip slap hammer were attempted. A clamshell osteotomy was attempted and when it nearly spanned, the femur the nail gave. The osteotomy proceeded with a sequential cable fixation to close the osteotomy. The lateral periprosthetic femur plate was used to neutralize the femur and reattach the trochanter. The proximal trochanter screw was disengaged which allowed making a proximal neck cut, the head and ligamentum teres were removed and the head was sized. The patient outcome was unknown. This report is for one (1) unknown trochanteric fixation nail advanced (tfna) nail. This is report 1 of 5 for (b)(4).
 
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Brand NameUNK - NAILS: TFNA
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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12738627
MDR Text Key279612292
Report Number2939274-2021-06441
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 Other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
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
Date Manufacturer Received12/03/2021
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: 11/02/2021 Patient Sequence Number: 1
Treatment
UNK - NAIL HEAD ELEM: TFNA LAG SCREW; UNK - PLATES: TRAUMA; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: TRAUMA
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