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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN AXSOS III PLATE IMPLANT

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STRYKER GMBH UNKNOWN AXSOS III PLATE IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problems Bent (1059); Break (1069)
Patient Problem No Information (3190)
Event Date 06/01/2016
Event Type  Injury  
Manufacturer Narrative
This investigation is revision 1 and is linked with (b)(4), which is the 2nd revision. The reported event that an «unk axsos iii plate» broke and had to be revised, could not be confirmed. Based on the provided surgical procedure and x-rays, the reported plate was revised not because it was broken but because it was bent. Since the actual involved plate was not returned, a visual inspection could not be performed. However, from the provided x-rays it is evident that the plate is not broken, but slightly deformed/bent. As per surgical procedure, the patient had an open distal femoral intra-articular fracture, as a result of a high energy trauma. The reported plate was implanted in (b)(6) 2016. X-rays from (b)(6) 2016, show a slightly bend plate (outwards). On the (b)(6) 2016, the customer proceeded with bone transplantation. As per surgical procedure: the plan was to use a cable to move the fragment down and fill the gap. By using a system of pulleys, the power can be increased but the speed of travelling will slow down. X-rays from (b)(6) 2016, showed a slightly bent plate (inwards). The fragment was transported for about 6 and a half months, and in (b)(6) 2017, all the transporting metalwork (screw, cable and half pins) was removed. The x-rays showed that the plate is back to its former shape, which indicates that the bending of the plate was caused by the cable. In (b)(6) 2017, the plate was removed and was replaced by a new one. As per ifu ((b)(4)): ¿stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones. The use of these devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. No fracture fixation device that is subject to material fatigue can be expected to withstand activity levels in the same way as would a normal healthy bone. The fracture fixation system, therefore, will not be as strong, reliable or durable as a normal human bone. ¿ please be aware that stryker implants are recommended to be used only for temporary bone fixation, and not as normal bone structures. Therefore, a bone transplantation can be considered as an off label use. As per ifu ((b)(4)): ¿ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system. ¿ as per op. Tech. ((b)(4)), ''the axsos 3 titanium locking plate system is intended for long bone fracture fixation, such as: ¿ diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures ¿ non-unions and malunions ¿ normal and osteopenic bone ¿ osteotomies ¿ periprosthetic fractures of the femur and proximal tibia. The physician¿s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of failure include: ¿ any active or suspected latent infection or marked local inflammation in or about the affected area ¿ compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site ¿ bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and / or fixation of the devices ¿ obesity. An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to failure of the device itself. '' according to the surgical procedure, the customer ¿would try and bend the plate to accommodate the greater trochanter, but not all plates will allow bending¿. As per ifu ((b)(4)), ¿contouring or bending of an implant should be avoided where possible, because it may reduce its fatigue strength and can cause failure under load. If contouring is necessary, allowed by design or prescribed by stryker, the physician should avoid sharp bends, reverse bends or bending the device at a screw hole. Such action must be performed with stryker instruments and in accordance with the specified procedures¿. Therefore, a misuse/mishandling of the implant could definitely lead to a compromised integrity and as a result to a potential deformation or even breakage of the implant. Based on investigation, the root cause would be attributed to a user related issue, due to an off-label use of the implant, which resulted in the overload of the plate all these 10 months. However, please bear in mind that more detailed information about the complaint event as well as the affected devices must be available in order to determine the exact root cause. A review of the device history for the reported lot was not possible because the lot number of the device was not communicated. No corrective actions are required at this time. A review of the labeling did not indicate any abnormalities. If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
The surgeon reported that the axsos iii plate broke and was revised. The patient had required bone transplantation and the revision was planned / expected.
 
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report. Device disposition is unknown.
 
Event Description
The surgeon reported that the axsos iii plate broke and was revised. The patient had required bone transplantation and the revision was planned / expected.
 
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Brand NameUNKNOWN AXSOS III PLATE
Type of DeviceIMPLANT
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 Key6924756
MDR Text Key255654276
Report Number0008031020-2017-00584
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 12/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/06/2017 Patient Sequence Number: 1
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