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U.S. Department of Health and Human Services

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

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SYNTHES BRANDYWINE BUTTRESS/COMPRESSION NUT FOR 357.369 TRACTION, APPARATUS, NON-POWERED Back to Search Results
Catalog Number 357.371
Device Problem Separation Failure (2547)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/22/2015
Event Type  Malfunction  
Manufacturer Narrative

No reported patient involvement. Device is an instrument and is not implanted or explanted. The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn as no product was received. Device history record review: manufacturing date: may 19, 2003 - manufacturing site: (b)(4). 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. Device 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 blade guide sleeve for trochanteric fixation nails and a buttress compression nut could not be pulled apart. It appeared that the threads of the guide sleeve were damaged, which prevented threading and passing of the buttress nut. The issue was discovered during sterile processing with no reported patient or procedural involvement. This report is 2 of 2 for (b)(4).

 
Manufacturer Narrative

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.

 
Manufacturer Narrative

A product investigation was completed: the complaint condition for the 357. 369 lot number 6320172 blade guide sleeve and 357. 371 lot number 4546697 buttress/compression nut was likely caused by numerous years of consistent use and possibly rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design related deficiency. Per the technique guide, the 357. 369 blade guide sleeve and 357. 371 buttress/compression nut are instruments routinely used in the titanium trochanteric fixation nail system. The devices were returned and reported to not pull apart. This condition is confirmed; the two devices were received in customer quality separately, but upon testing them together the devices became stuck and unable to be detached from one another using a moderate amount of force. It is likely that numerous years of consistent use and possibly rough handling during surgery or sterile processing has led to thread deformation on these devices and ultimately this complaint condition. The 357. 369 sleeve was manufactured in april 2010 and is over five years old. The 357. 371 nut was manufactured in may 2003 and is over twelve years old. The returned devices are in fairly worn condition consistent with their respective ages. 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. The complaint condition for this device can be replicated. The risk assessment adequately addresses the complaint event. No non-conformance reports germane to the complaint condition were generated during the production of this device. 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 BRANDYWINE
1303 goshen parkway
west chester PA 19380
Manufacturer (Section G)
SYNTHES BRANDYWINE
1303 goshen parkway
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5360632
MDR Text Key36083663
Report Number2530088-2016-10005
Device Sequence Number1
Product Code HST
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 12/22/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/12/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number357.371
Device LOT Number4546697
OTHER Device ID Number(01)10886982196057(10)4546697
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/11/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/19/2003
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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