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U.S. Department of Health and Human Services

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

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SYNTHES MONUMENT BUTTRESS/COMPRESSION NUT FOR 357.369 TRACTION, APPARATUS, NON-POWERED Back to Search Results
Catalog Number 357.371
Device Problems Failure To Adhere Or Bond; Device Operates Differently Than Expected
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.

 
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Brand NameBUTTRESS/COMPRESSION NUT FOR 357.369
Type of DeviceTRACTION, 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 Key5394056
Report Number1719045-2016-10090
Device Sequence Number1
Product CodeHST
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/27/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number357.371
Device LOT Number7506796
OTHER Device ID Number(01)10886982196057(10)7506796
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/22/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/26/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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