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

Catalog Number 357.371

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

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

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information was not provided by reporter.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 while inserting the helical blade of a trochanteric fixation nail (tfn) system the buttress nut/aiming arm connection was failing.The buttress nut/aiming arm connection continued to unlock while the helical blade was being inserted and had only a few millimeters to go to be completed.The surgery was successfully completed with no additional intervention or reported surgical delay.There was no harm to the patient and the surgical outcome was good.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device investigation summary - the returned 357.371 lot number 7506796 buttress/compression nut and the 357.366 lot number 1870340 aiming arm show some markings and signs of wear although nothing that would impair their function.The devices function together as designed.A visual inspection, dimensional inspection, drawing review, and dhr review were performed as part of this investigation.No product design issues or discrepancies were observed, and therefore review to the applicable dcrm is not required.The cause of this complaint condition cannot be determined.The devices were reported to have repeatedly come apart during surgery.This complaint is unconfirmed.The complaint condition cannot be replicated.When tested with a sample 357.369 blade guide sleeve, the devices easily assemble and do not come apart even when subjected to a moderate amount of force.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 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: 5394056
• MDR Text Key: 36954785
• Report Number: 1719045-2016-10090
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 7506796
• Other Device ID Number: (01)10886982196057(10)7506796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 01/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2013
• 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