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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 Failure To Adhere Or Bond
Event Type  Malfunction  
Manufacturer Narrative

Patient information is not available for reporting. Date device found worn in surgery is not known. Udi: (b)(4). Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Concomitant device therapy date is not known. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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

It is reported the surgeon noted a buttress compression nut for a guide sleeve for trochanteric fixation nails is worn and will not hold during surgery. No further information was provided. Concomitant devices reported: guide sleeve (part 357. 369, lot unknown, quantity 1). This report is for one (1) buttress/compression nut. This is report 1 of 1 for (b)(4).

 
Manufacturer Narrative

Device history records review was completed for part# 357. 371, lot# 4436456. Supplier: (b)(4), release to warehouse date: nov 01, 2002. Review of the device history records(s) showed that there are no potential issues during the manufacture of the product that would contribute to this complaint condition. The device was received and the product evaluation is in progress. No conclusion can be drawn. 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

An additional instrument was available in the operating room to complete the surgery. No delay in surgery. Surgery was completed successfully. Patient is reported in stable condition.

 
Manufacturer Narrative

Device was used for treatment, not diagnosis. A product development investigation was performed for the subject device. The 357. 371 lot number 4436456 buttress/compression nut was returned and reported to have become worn out and no longer hold. This complaint condition was likely caused by over fourteen 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 and drawing review were performed as part of this investigation. This complaint is confirmed. No new malfunctions were observed during the course of this investigation. The 357. 371 buttress/compression nut is an instrument routinely used in the titanium trochanteric fixation nail system (technique guide). The device was returned and reported to have become worn out and no longer hold. This condition is confirmed; the outer edge of the lip which connects to the aiming arm shows significant wear and deformation. In addition to significant wear on the mating aiming arm, this likely led the device not holding together. The device was manufactured in 11/2002 and is over fourteen years old. The balance of the returned device is in otherwise fair condition with some superficial wear along the outer knurled edge. Drawing was 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. Whether the complaint condition for this device can be replicated is not applicable for this condition. All measurements have been performed by calipers. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. 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
michael cote
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key6482482
Report Number1719045-2017-10295
Device Sequence Number1
Product CodeHST
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/23/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number357.371
Device LOT Number4436456
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/07/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2002
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/11/2017 Patient Sequence Number: 1
Treatment
GUIDE SLEEVE (PART 357.369, LOT UNKNOWN, QTY 1)
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