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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 95MM-STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 95MM-STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 456.304S
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2017
Event Type  malfunction  
Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation. Device was implanted on (b)(6) 2017 and is currently implanted. Explant date is non-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.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient weight and date of birth are not available for reporting. Additional product code hwc. Device was implanted on (b)(6) 2017 and is currently explanted. Explant date is non-applicable. 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. 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 a patient had initial surgery on (b)(6) 2017 for treatment of a sub-trochanteric femur fracture. Patient was implanted with one (1) trochanteric fixation nail (tfn), one (1) 11. 0 mm ti helical blade and one (1) 4. 5 mm distal locking screw. As the surgeon was using the slide hammer while inserting the helical blade implant with the helical blade coupling screw, the distal knob on the coupling screw broke off intraoperatively, and fell on the operating room floor. Due to the force that the surgeon used to disengage the helical blade implant from the tfn instruments, the aiming arm instrument and the helical blade inserter instrument became warped. Also, the buttress compression nut became stuck inside the blade guide sleeve. The surgeon successfully disengaged all the instruments from the implant, and proceeded with the surgery. No fragments were generated. Surgery was completed successfully with 30-40-minute time delay. Patient is reported in stable condition. This is report 4 of 4 for (b)(4).
 
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Brand Name11.0MM TI HELICAL BLADE 95MM-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)
ELMIRA
35 airport road
horseheads NY
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7127997
MDR Text Key270883447
Report Number2939274-2017-50363
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011857
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number456.304S
Device Catalogue Number456.304S
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 Received01/17/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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