• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT BUTTRESS/COMPRESSION NUT FOR 357.369357. TRACTION, APPARATUS, NON-POWERED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES MONUMENT BUTTRESS/COMPRESSION NUT FOR 357.369357. 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 08/05/2015
Event Type  Malfunction  
Manufacturer Narrative

Device was used for treatment, not diagnosis. Additional narrative: patient information was not provided by reporter. Event date: unknown. Additional device product code is gxl. Device is an instrument and is not implanted/explanted. 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 subject device has been received and is currently in the evaluation process. 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 as the surgeon was trying to advance a blade guide sleeve down the bone, the buttress nut would not stay coupled into the aiming arm. The event occurred during the implantation of a trochanteric fixation nail system (tfn) in the patient's left hip. There was no reported surgical delay and another instrument was available. The procedure was successfully completed without further incident. This report is 1 of 1 for (b)(4).

 
Manufacturer Narrative

Device was used for treatment, not diagnosis. A product development investigation was performed for the subject device (part number 357. 371, buttress/compression nut for 357. 369, lot number 6937153). The subject device was returned for the complaint condition would ¿not stay coupled into the aiming arm. ¿ the returned instruments (buttress/compression nut: 357. 371 lot 6937153 and aiming arm: 357. 366 lot 4781336) were examined and the complaint condition of ¿does not fit with other parts¿ was able to be confirmed as the buttress/compression nut did not securely lock into the returned aiming arm. The portion of the nut which interfaces with the aiming arm shows wear (nicks/gouges) consistent with repeated use/rough handling. A known good buttress/compression nut was utilized to test the returned aiming arm and created a secure assembly; as such the aiming arm was found to function as intended. The buttress/compression nut was manufactured 7/25/2012 and has been in the field for over three years. The wear and tear present (nicks and gouges on interface) are consistent with rough handling over a period of time. Relevant drawings for the returned instruments were reviewed. The design, materials and finishing processes were found to be appropriate for the intended use of these devices. There were no ncr¿s associated with this lot. A definitive root cause was unable to be determined; however, the failure mode is consistent with wear from use/rough handling. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBUTTRESS/COMPRESSION NUT FOR 357.369357.
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 Key5019287
Report Number1719045-2015-10524
Device Sequence Number1
Product CodeHST
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number357.371
Device LOT Number6937153
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/13/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/25/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-