MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 TI 4.0MM / L30MM; PLATE, FIXATION, BONE

Catalog Number	661030S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event that a tibial plate, proximal medial axsos 3 ti for left tibia 8 hole / l123mm was alleged of poor fixation could be confirmed thanks to the provided x-rays.Based on investigation, the root cause was attributed to be user related.The failure was caused by the use of incorrect plate size.The device inspection revealed, in line with the reported event, some small plastic deformations in the holes where the screws backed out or broke.Further testing regarding the locking mechanism found that the locking mechanism of the plate is fully functional.A clinical statement was requested for the evaluation of the provided medical data.For the x-rays taken immediately after first surgery it was stated: ¿orif of an unstable proximal tibia fracture with an axsos proximal medial tibia plate.Correct fragment reduction and correct positioning of the hardware.But, the plate is distally only fixed with three screws, whereby only the most distal screw is placed outside the fracture zone.¿ [original statement(s)] whereas for what the x-rays taken when failure was identified is concerned: ¿all distal screws are loosened and slightly backed out.The distal portion of the plate is somewhat separated from the bone surface and the most distal screw proximal to the fracture gap is broken.Despite the implant failure there is only little displacement, which indicates that the fragments are connected by increasing callus formation and sturdy scar tissue.But, approx.4 months after initial surgery the fracture gaps are still clearly visible, which indicates a delayed union.¿ [original statement(s)] overall: ¿clinical statement: for this kind of fracture orif with an anatomically pre-shaped axsos medial and/or lateral locking plate [¿] is rated as state of the art.Therefore, the indication is estimated as absolutely correct.Initial fragment reduction and fixation have been made correctly.But, the distal fragment is only fixed with three screws, whereby two of them are positioned in the fracture zone.It has to be considered that in the case of an unstable fracture nearly all forces and bending moments have to transmitted by those three screws alone.Usually, a minimum of five to six screws in each fragment are recommended to achieve better load-balancing.Alternatively, a two plate construct (medial and lateral locking plate) should be considered in such an unstable fragment constellation.Clinical conclusion: the given case presents a typical implant failure caused by a distally too short plate resulting in overloading and loosening of the three screws in the distal fragment.¿ [original statement(s)] in addition to the clinical statements and device inspection it has not been reported whether the patient was compliant to the surgeon¿s instructions.If she was not, this would also contribute to the event.Note, as stated in the ifu (v15013): ¿4 warnings and precautions: implant selection and sizing: the correct selection of the fracture fixation appliance is extremely important.Failure to use the appropriate appliance for the fracture condition may accelerate clinical failure.Failure to use the proper component to maintain adequate blood supply and provide rigid fixation may result in loosening, bending, cracking or fracture of the device and/or bone.The correct implant size for a given patient can be determined by evaluating the patient¿s height, weight, functional demands and anatomy.Every implant must be used in the correct anatomic location, consistent with accepted standards of internal fixation.Informing the patient: the implantation affects the patient¿s ability to carry loads and her/his mobility and general living circumstances.For this reason, the surgeon must counsel each patient individually on correct behavior and activity after the implantation.The surgeon must warn patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future.¿ [original statement(s)] a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
On (b)(6) 2016, the patient underwent the surgery with the axsos proximal tibia lateral plate.On (b)(6) 2016, the surgeon confirmed x-ray.And he found that the screw inserted in the bone are broken and loosening.Therefore the surgeon did the revision surgery on(b)(6) 2016.

• Brand Name: LOCKING SCREW AXSOS 3 TI 4.0MM / L30MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 6498956
• Report Number: 0008031020-2017-00240
• Device Sequence Number: 1202267
• Product Code: HRS
• UDI-Device Identifier: 04546540685872
• UDI-Public: (01)04546540685872(17)200430(10)J17206
• Combination Product (Y/N): N
• PMA/510(K) Number: K123964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 661030S
• Device Lot Number: J17206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR