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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/LT-STERILE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/LT-STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.003.461S
Device Problem Use of Device Problem (1670)
Patient Problems No Code Available (3191); Malunion of Bone (4529)
Event Date 03/03/2019
Event Type  Injury  
Manufacturer Narrative
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) 2019, the surgeon called and asked which side (left or right) was an expert lateral femoral nail implanted and was informed that it was implanted on the right femur. Originally, the patient had an open reduction internal fixation (orif) surgery for intramedullary nailing of the right femur due midshaft femur fracture using a left lateral entry nail last (b)(6) 2019. However, the nail that was used was for the left. Thus, a planning for removal of the nail was successfully done and was replaced with right left on (b)(6) 2019. There was no known defect with the implant. Patient status is unknown. Concomitant device/s reported: unknown screws (part# unknown, lot# unknown, quantity unknown) and unknown end caps (part# unknown, lot# unknown, quantity unknown). This report is for one (1) 11mm ti lateral entry femoral recon nail-ex/400mm/lt-sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name11MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/LT-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 Key8837021
MDR Text Key152511120
Report Number2939274-2019-59425
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.003.461S
Device Catalogue Number04.003.461S
Device Lot Number7322448
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 Received10/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/18/2013
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: 07/29/2019 Patient Sequence Number: 1
Treatment
UNK - END CAPS; UNK - SCREWS: TRAUMA
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