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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 400MM/RIGHT-STERILE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 400MM/RIGHT-STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.037.260S
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Reporter is synthes sales consultant. A review of the device history records has been requested. The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 a patient underwent a revision surgery on (b)(6) 2018 as it was found out that a trochanteric femoral nailing advanced (tfna) nail broke at the junction of the helical blade a few months after a patient had a hip fracture fixed with tfna. The nail was removed, and a total hip arthroplasty was done. There were no fragments generated from the broken device and it was removed without incident. Surgical delay and procedure outcome is unknown. Patient status is unknown. Concomitant devices reported: tfna fenestrated helical blade 100mm (part# 04. 038. 400, lot# h557037, quantity 1); screw (part # unknown, lot # unknown, quantity 1). This report is for one (1) tfna nail. This is report 1 of 1 for complaint (b)(4).
 
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Brand Name12MM/130 DEG TI CANN TFNA 400MM/RIGHT-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 Key8130389
MDR Text Key129295010
Report Number2939274-2018-55270
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,Followup,Followup
Report Date 11/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.260S
Device Catalogue Number04.037.260S
Device Lot NumberH562967
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2018
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: 12/04/2018 Patient Sequence Number: 1
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