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

Catalog Number 357.371

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2015

Event Type  malfunction  

Event Description

It was reported that during a trochanteric fixation nail (tfn) surgery, the outer sleeve and buttress nut cross-threaded.It was reported that after surgery was successfully completed both parts got stuck together discovered on back table and would not come apart.No surgical delay was reported and patient/status outcome was fine.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.A review of the device history records was performed and no complaint related issues were found.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.Additional narrative: patient information was not provided by reporter.A product development investigation was performed for the subject device (357.371 buttress/compression nut).The 357.369 blade guide sleeve and 357.371 buttress/compression nut (subject device) are instruments routinely used in the titanium trochanteric fixation nail system per the technique guide.The devices were returned and reported to have become cross threaded together.This condition is confirmed; the buttress/compression nut (subject device) is firmly stuck two centimeters down the threading from the proximal end of the blade guide sleeve and cannot be dislodged with a reasonable amount of force.The buttress/compression nut was manufactured in 10/2011 and is over three years old.The balance of the nut is in fairly worn condition with several scrape marks along the knurled outer edge.The balance of the sleeve is in fair condition with a couple of threads that appear to be deformed.The associated drawings for the subject device were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned devices does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.It is likely that several years of use and sterile processing cycles has led to this complaint condition.Rough handling during surgery or in sterile processing may have also contributed to this condition.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 MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4634200
• MDR Text Key: 5615291
• Report Number: 1719045-2015-10190
• 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: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• 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: 6722770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2011
• 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