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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC BUTTRESS/COMPRESSION NUT FOR 357.369 TRACTION,APPARATUS,NON-POWERED

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WRIGHTS LANE : SYNTHES USA PRODUCTS LLC BUTTRESS/COMPRESSION NUT FOR 357.369 TRACTION,APPARATUS,NON-POWERED Back to Search Results
Catalog Number 357.371
Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2017
Event Type  malfunction  
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.
 
Manufacturer Narrative
Product development investigation was completed. The buttress/ compression nut (357. 371) was received assembled on a blade guide sleeve (357. 369 lot 5009622) and was unable to be disassembled from the device due to deformation in the guide sleeve threads below the nut. No defects or deficiencies were identified with the buttress/ compression nut which would inhibit normal functionality, as such the complaint condition related to the nut is unconfirmed. The buttress/ compression nut is a component of the titanium trochanteric fixation nail (tfn) system intended for the intramedullary fixation of proximal femur fractures. The device is specifically utilized for the insertion of the head element into the nail. Information is provided per technique guides. Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture). The design, materials and finishing processes were found to be appropriate for the intended use of this device. No dimensional analysis is applicable as the complaint condition was unable to be replicated or confirmed. A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number. Device history records review was completed for part # 357. 371, supplier lot # t102368, synthes lot # 6196481. Supplier: (b)(4), release to warehouse date: aug 04, 2009. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. 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. Device is an instrument and is not implanted/explanted. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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 3 of 4 for (b)(4).
 
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Brand NameBUTTRESS/COMPRESSION NUT FOR 357.369
Type of DeviceTRACTION,APPARATUS,NON-POWERED
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
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7126728
MDR Text Key253311695
Report Number2939274-2017-50357
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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
Report Date 11/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number357.371
Device Lot NumberT102368
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2017
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
Date Device Manufactured08/04/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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