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

Catalog Number 357.371

Device Problem Mechanical Jam (2983)

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

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Part 357.371, lot 5519091: release to warehouse date: july 18, 2007.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 a patient underwent a trochanteric fixation nail system (tfn) procedure for a hip fracture (side unknown) on (b)(6) 2016.During the procedure, the buttress compression nut and the blade guide sleeve were stuck together.Both devices are dented.The buttress compression nut will not unscrew from the threads of the blade guide sleeve for the trochanteric fixation nails.The threads from the blade guide sleeve are dented and it won¿t unscrew.The operation was already completed; the devices were noticed to be stuck together when the sterile processing department technician was taking the devices apart.The reporter was not sure if this was a revision or an initial surgery.The procedure was completed successfully with no reports of surgical time delay or medical intervention.The patient¿s post-operative status was noted to be stable.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the 357.371 lot number 5519091 buttress/compression nut and 357.369 blade guide sleeve with unknown lot number were returned and reported to have become stuck together.This complaint condition was likely caused by several years of consistent use and possible rough handling during surgery or sterile processing leading to deformation of threads on the device; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, functional test, and drawing review were performed as part of this investigation.This complaint is confirmed.Per the technique guide, the 357.371 buttress/compression nut and the 357.369 blade guide sleeve are instruments routinely used in the titanium trochanteric fixation nail system.The devices were returned and reported to have become stuck together.This condition is confirmed; the buttress/compression is jammed near the proximal end of the sleeve, obscuring the lot number.The nut is entirely immobile and will not move even when applying a moderate amount of force.It is likely that several years of use and possible rough handling during surgery or sterile processing has led to deformed threads causing this complaint condition.The nut was manufactured in july 2007 and is over nine years old.The balance of each of the returned devices is in fairly worn condition with numerous markings along the length of the sleeve and around the knurled circumference of the nut.The relevant drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.Upon review of the device history record, no non-conformance reports germane to the complaint condition were generated during the production of this device.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6240658
• MDR Text Key: 64590900
• Report Number: 2530088-2017-10003
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 10886982196057
• UDI-Public: (01)10886982196057(10)5519091
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• 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: 5519091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2007
• 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