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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/125 DEG TI CANN TFNA 200MM - STERILE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/125 DEG TI CANN TFNA 200MM - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.213S
Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920)
Patient Problems Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown 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. (b)(4). 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 an unknown procedure using a trochanteric femoral nailing advanced (tfna) system. During the surgery, while installing the tfna and approaching the intramedullary (im) canal, it was realized that the canal was too tight distally. The canal was reamed after cabling the femur to reduce a section of the fracture. After reducing the fracture with the unknown cables, the surgeon began reaming for an unknown nail and installed the nail. Then the surgeon began the proximal locking with an unknown helical blade and everything was fine. However, when the surgeon began attempting to lock distally by drilling the hole, the surgeon heard the chattering of the bone and the drill would not advanced any further. The surgeon changed the drill and drilled again, the aiming arm and insertion handle to tfna were tight and attached properly with everything in the proper location. Finally, the surgeon then removed the aiming arm and insertion handle and attempted to freehand the distal locking screw when he heard a chattering. The surgeon stop drilling and could not drill for the distal locking hole and finished without the distal locking screw. Procedure and patient status were unknown. Concomitant devices: unknown reamer (part# unknown, lot# unknown, quantity 1). Unknown cable (part# unknown, lot# unknown, quantity unknown). Unknown tfna helical blade (part# unknown, lot# unknown, quantity 1). This report is for one unknown tfna nail. This is report 1 of 6 for (b)(4).
 
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Brand Name12MM/125 DEG TI CANN TFNA 200MM - STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9855685
MDR Text Key193376868
Report Number2939274-2020-01367
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
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,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.213S
Device Lot Number25P8948
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 Received03/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2019
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: 03/19/2020 Patient Sequence Number: 1
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