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

MAUDE Adverse Event Report: SYNTHES BRANDYWINE BUTTRESS/COMPRESSION NUT FOR 357.369 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 BRANDYWINE BUTTRESS/COMPRESSION NUT FOR 357.369 TRACTION, APPARATUS, NON-POWERED Back to Search Results
Catalog Number 357.371
Device Problem Unintended Movement
Event Date 09/29/2016
Event Type  Malfunction  
Manufacturer Narrative

(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. 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 was reported that during the initial trochanteric fixation nail (tfn) surgery performed on (b)(6) 2016 to treat proximal femur fracture, the helical blade got stuck inside the trochanteric fixation nail. During the procedure, the surgeon assembled the aiming arm, blade guide sleeve, compression nut, helical blade inserter, helical blade coupling screw, guide wire, trocar, cannulated connecting screw and insertion handle as per instructions to implant helical blade and nail. When the surgeon was inserting the helical blade it wouldn't go through the nail. The surgeon kept hammering but the helical blade still wouldn't go through and got stuck inside the nail. The surgeon believes the instruments which were used to implant the nail and helical blade may be worn out and loose; they are not maintaining their integrity in terms of tightness and because of that there might be misalignment. At this point the surgeon decided to take out the nail and blade. When surgeon was taking out the nail the locking mechanism of the nail broke inside the nail. All of the broken pieces were retrieved. The surgeon then requested a different instrument set and implanted a new 95mm helical blade and a new tfn nail. Reportedly there was between a surgical delay of forty-five (45) to sixty (60) minutes due to the reported issues. The patient's surgery was also complicated because of her preexisting pulmonary embolism treated with blood thinners and patientrefusal of blood transfusion prior to surgery because of her religion. Surgery was completed successfully with no other medical intervention. It took a while to stabilize patient after the surgery as patient lost extra blood due to her preexisting condition of pulmonary embolism and due to surgical delay caused by reported issues. This is report 5 of 11 for (b)(4).

 
Manufacturer Narrative

A product development investigation was performed for the subject devices. The returned instruments were examined and the construct was able to be to be assembled and found to target the nail¿s proximal locking as intended. Upon further examination the following deficiencies were identified with the returned devices: nail: broken locking mechanism, aiming arm: significant wear resulting in a loose connection with the buttress/compression nut/guide sleeve assembly, 11. 0mm/3. 2mm wire guide and 3. 2mm trocar: missing yellow epoxy color coating, helical blade inserter: broken locating pin for alignment indicator. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. A visual inspection, functional test, and drawing review were performed as part of this investigation. No product design issues or discrepancies were observed. This complaint is confirmed. The remainder of the devices (listed below) showed no defects of deficiencies which may have contributed to the reported complaint condition, as such the complaints of loose relevant to the following devices are unconfirmed: helical blade (456. 305 lot h088969), blade guide sleeve (357. 369 lot 5009622), buttress/compression nut (357. 371 lot 4941439), helical blade coupling screw (357. 377 lot is10280), cannulated connecting screw (357. 397 lot 6649035), insertion handle (357. 411 lot 4762525), nut for shaft (360. 244. 2 lot unknown) relevant drawings for the returned devices were reviewed (both current revision and from the time of manufacture). The design, materials and finishing processes were found to be appropriate for the intended use of these devices. A device history review was performed for the returned devices' lot numbers and no relevant material review records (mrrs), non-conformance reports (ncrs) or complaint-related issues were identified with the lot numbers which may have contributed to the complaint conditions. 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

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Part 357. 371, synthes lot 4941439: release to warehouse date: may 13, 2005. 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 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
mark vornheder
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key6041310
Report Number2520274-2016-14979
Device Sequence Number1
Product CodeHST
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number357.371
Device LOT Number4941439
OTHER Device ID Number(01)10886982196057(10)4941439
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/31/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/13/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-