MAUDE Adverse Event Report: SYNTHES BRANDYWINE BUTTRESS/COMPRESSION NUT FOR 357.369; TRACTION,APPARATUS,NON-POWERED

Catalog Number 357.371

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2014

Event Type  malfunction  

Event Description

During a trochanteric fixation nail (tfn) procedure, the buttress compression nut would not release from the 130 degree aiming arm.The blade guide sleeve was reported to have damaged threads by the surgeon and would not properly thread.The helical blade coupling screw falls off when the helical blade inserter is decoupled.When the coupling screw is removed the back end falls off.This is report number 1 of 5 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.A review of the device history records has been requested.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

A review of the device history records was completed: troutman industries, inc.Manufactured the buttress compression nut, part number 357.371, lot 5501483.Initially, the part conformed to the supplier¿s certificate of conformance and synthes final inspection sheet.A product development evaluation was completed: the buttress/compression nut (357.371 lot 5501483) was received with the inner threads in good condition.The distal flange has a 6 x 1mm gouge on the outermost radius.A top level drawing for the buttress/compression nut was reviewed and found to be suitable to determine the intended device design, application and dimensional conformity.The nut was found to have met the drawing specifications.The returned components were assembled to complete the insertion construct in an attempt to replicate the complaint condition.The mating components used were: a blade guide sleeve (357.369 lot 5491547) and a 130 degree aiming arm (357.366 lot 5574498).The compression nut was threaded onto the blade guide sleeve and the assembly was inserted and locked into the aiming arm.The locking mechanism on the aiming arm was able to retain and release the compression nut on each attempt.The aiming arm was able to function as intended: retain the buttress/compression nut when engaged and release it when the slide plate is pressed.The complaint condition of the nut being unable to be released from the aiming arm was not able to be replicated, therefore the complaint is unconfirmed.The complaint is not valid from a design perspective, as a design issue did not lead to the complaint condition.The buttress/compression nut/guide sleeve assembly was checked against the same components which caused the ¿will not release¿ condition and the assembly was found to function correctly.As the failure mode was unable to be replicated, the complaint is deemed unconfirmed.The design of the buttress/compression nut is adequate for its intended use and did not 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.

Event Description

It was reported there was a one minute delay in the procedure.It was the reported the patient status/outcome was good.

• Brand Name: BUTTRESS/COMPRESSION NUT FOR 357.369
• Type of Device: TRACTION,APPARATUS,NON-POWERED
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4069023
• MDR Text Key: 4813256
• Report Number: 2530088-2014-10260
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• 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: 5501483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2007
• 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: 29 YR