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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 380MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.037.228S
Device Problem Break (1069)
Patient Problems Death (1802); Failure of Implant (1924)
Event Type  Death  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 the patient underwent hardware removal on an unknown date due to the broken implanted long right trochanteric femoral nail advance (tfna) nail which failed at the helical blade site. The broken implants were removed without issue or further consequence to the patient. X-ray was taken intraoperatively proving removal of all implants. Surgical procedure was successfully completed. Patient outcome is unknown. Concomitant device reported: helical blade (part #:04. 038. 290s, lot#: h279255, quantity #1), unknown locking screw (part unknown, lot unknown, quantity #1). This report is for one (1) 12mm/125 deg ti cann tfna 380mm/right - sterile. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank. (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
Hardware removal occurred on (b)(6) 2018. Patient died on (b)(6) 2018. Concomitant devices: helical blade (part: 04. 038. 290s, lot: h279255, quantity: 1), 5. 0mm titanium (ti) locking screw 38mm (part: 04. 005. 528, lot: unknown, quantity: 1), 5. 0mm ti locking screw 40mm (part: 04. 005. 530, lot: unknown, quantity: 1).
 
Manufacturer Narrative
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
Updated event description: it was reported that the patient underwent hardware removal on (b)(6) 2018 due to the broken implanted long right trochanteric femoral nail advance (tfna) nail that failed at the helical blade site. The broken implants were removed without issue or further consequence to the patient. The original surgery took place on (b)(6) 2017. X-ray was taken intraoperatively proving removal of all implants. The procedure was successfully completed with unknown surgical delay. The patient merely stood up from a seated position causing immediate right hip pain. The hip failed on or about (b)(6) 2018 resulting in a hospitalization on (b)(6) 2018. The patient developed severe sepsis causing her death on or about (b)(6) 2018.
 
Manufacturer Narrative
Corrected data: g4: awareness date reported on follow up 5 report as november 06, 2018 but should have been november 06, 2019. 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.
 
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Brand Name12MM/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)
SYNTHES MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key7942421
MDR Text Key123062763
Report Number2939274-2018-54210
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.228S
Device Catalogue Number04.037.228S
Device Lot NumberH085574
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2016
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: 10/08/2018 Patient Sequence Number: 1
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