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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.037.128S
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
Patient height reported as 5¿0. Date of implant/explant is not known. 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. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 patient was implanted with the trochanteric fixation nail advanced (tfna) nail, helical blade, and two (2) locking screws on unknown date. On another unknown date, it was revealed the tfna nail broke where it interfaces with the helical blade. Patient was returned to surgery on unknown date and revised to a total hip construct. Concomitant devices reported: tfna helical blade 85mm (04. 038. 285s, lot number unknown, quantity 1), 5. 0mm locking screw with t25 stardrive 40mm (04. 005. 530s, lot number unknown, quantity 1), 5. 0mm locking screw with t25 stardrive 64mm (04. 005. 554, lot number unknown, quantity 1). This report is for one (1) 11mm 125 degree tfna nail 380mm. This is report 1 of 1 for (b)(4).
 
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Brand Name11MM/125 DEG TI CANN TFNA 380MM/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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7781255
MDR Text Key117130713
Report Number2939274-2018-53317
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.128S
Device Catalogue Number04.037.128S
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 Received07/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/14/2018 Patient Sequence Number: 1
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