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

Catalog Number 357.371

Device Problem Fitting Problem (2183)

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

Event Date 08/28/2016

Event Type  malfunction  

Manufacturer Narrative

This device was used for treatment, not diagnosis.(b)(4).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.No ncrs were generated during production.Review of device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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 during a tfn procedure when the surgeon tried passing the helical blade through a trochanteric fixation nail (tfn) nail; it came in contact with the nail using the percutaneous aiming arm.After the tfn was reamed and inserted, the surgeon finally got the blade to go through the blade but was having problems going through the nail.There were two sets opened during the tfn case with similar problems experienced with both sets.Also, the buttress nuts kept coming disengaged from the 130 degree aiming arm.There was a fifteen (15) minute delay due to this incident.It was reported that the surgery was completed successfully without any patient harm and the patient was stable.Concomitant devices reported: 130 degree aiming arm (357.366, lot unknown, quantity 2), helical blade coupling screw (357.377, lot unknown,quantity 2), blade guide (357.369 lot unknown, quantity 2) percutaneous insertion handle for tnf (357.418, unknown lot, quantity 1) percutaneous cannulated connecting screw (357.419, unknown lot quantity 1).This report is 4 of 4 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the aiming arms and nuts were returned and reported to have been disengaging from one another during surgery.This condition is confirmed; all four devices when tested with test sample mating parts (357.371 lot number 5013309 and 357.366 lot number 4567002) disengaged immediately with nearly no application of force or pressure.It is likely that several years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.Upon investigation of the two 357.366 lot numbers 8525287 and 8893467 aiming arms it was determined that locking mechanism for the buttress/compression nuts is worn and will no longer hold the devices properly.This complaint condition was likely caused by over two years of consistent use and possible rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, functional test, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.This complaint is confirmed.Buttress/compression nut lot 4801877 was manufactured in august 2004 and is over twelve years old.Buttress/compression nut lot 6722770 was manufactured in october 2011 and is over five years old.Aiming arm lot 8525287 was manufactured in december 2013 and is over two years old.Aiming arm lot 8893467 was manufactured in august 2014 and is over two years old.The balance of each of the returned devices is in fairly worn and battered condition with several signs of wear.The relevant drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.Per the technique guide, the 357.371 buttress/compression nut and 357.366 aiming arm are instruments routinely used in the titanium trochanteric fixation nail system.It is likely that several years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.The returned 357.418 lot number 1955160 percutaneous insertion handle, two 357.369 lot numbers 6742014 and 7033801 blade guide sleeves, and two 357.377 lot numbers 5149879 and 7638322 helical blade coupling screws were received without allegation or identifiable 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

When the devices were being evaluated by the manufacturer, it was noted that the following concomitant parts have been determined to have contributed to the complaint condition: 130 degree aiming arms (part 357.366, lots 8255287 and 8893467).This is report 4 of 6 for (b)(4).

• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5948110
• MDR Text Key: 54631450
• Report Number: 1719045-2016-10683
• Device Sequence Number: 1
• Product Code: HST
• 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: 08/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• 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: 09/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2016
• 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
• Treatment: 130 DEGREE AIMING ARM (357.366, LOT UNKNOWN, QUANT; BLADE GUIDE (357.369 LOT UNKNOWN, QUANTITY 2; HELICAL BLADE COUPLING SCREW (357.377, LOT UNKNOWN; PERCUTANEOUS CANNULATED CONNECTING SCREW (357.419,; PERCUTANEOUS INSERTION HANDLE FOR TNF (357.418, UN
• Patient Age: 83 YR
• Patient Weight: 68