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

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.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).

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.

• Brand Name: BUTTRESS/COMPRESSION NUT FOR 357.369
• Type of Device: TRACTION,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 Key: 7126728
• MDR Text Key: 96033032
• Report Number: 2939274-2017-50357
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 10886982196057
• UDI-Public: (01)10886982196057(10)T102368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.371
• Device Lot Number: T102368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR