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

MAUDE Adverse Event Report: STRYKER GMBH LOCKING INSERT AXSOS 5.0MM LOCKING SET PLATE, FIXATION, BONE

  • 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
 

STRYKER GMBH LOCKING INSERT AXSOS 5.0MM LOCKING SET PLATE, FIXATION, BONE Back to Search Results
Catalog Number 370003S
Device Problems Failure To Adhere Or Bond (1031); Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/24/2017
Event Type  Malfunction  
Manufacturer Narrative

Once the investigation has been completed, any additional information will be reported in a supplemental report.

 
Event Description

The surgeon reported that he was using an axsos ts large frag plate with the inserts and struggled to get them into the plate. He ended up using a different solution. There was no adverse patient event. Update 12/12/2017 new information received. The surgeon reported that he undertook a periprosthetic fracture fixation in a very frail and elderly lady which the initial x rays were suggestive of possible stable implant and the decision was made to fix this with a plate construct rather than revising the total hip replacement as she was very frail. When the fracture was opened, it was indeed rather more comminuted than the original imaging had suggested and there was a very obvious need for a cable plate construct at the very least. Therefore, he cabled the proximal femur with dall miles cables and applied the axsos 2 plate to the femur, precontoured it and then before siting any screws, he sited the relevant locking guides into the plate. However, the customer only had six locking guides in the whole of the department. As the surgeon sited the locking screws into the distal aspect of the femur, the locking inserts, although they had clicked in to the holes, simply backed out, converting the locking plate into a non-locking construct. This happened repeatedly. The surgeon tried with a different axsos 2 plate and once again this happened with the second plate. The reason he used the axsos 2 plate initially was so he could use the stainless steel inserts to allow him to cable over the top of the plate onto the femur once the plate was applied. The surgeon further reported that at this stage it was apparent that this construct was not going to work and he had already drilled a number of drill holes through the femur, creating further stress risers. The surgeon reported that his only option at this point was to use an axsos 3 distal femoral locking plate turned upside down. This titanium plate was not able to be contoured to the bone, therefore stood off the bone, particularly posteriorly at the greater trochanter. Also, as the surgeon was changing to a titanium plate, he had to change the stainless steel cables to vitallium cables adding time to the operation. The distal femoral plate construct was applied but the inability to angle any of the locking screws past the implant provided very poor proximal fixation. Two failed attempts to implant axsos 2 plates which had to be removed during the case. Stress risers, reduced proximal fixation. As a result, the procedure lasted four and a half hours.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLOCKING INSERT AXSOS 5.0MM LOCKING SET
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7158299
MDR Text Key96460267
Report Number0008031020-2018-00007
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2020
Device Catalogue Number370003S
Device LOT NumberJ36254
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/29/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/02/2018 Patient Sequence Number: 1
-
-