MAUDE Adverse Event Report: STRYKER GMBH DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 TI FOR LEFT TIBIA 6 HOLE / L127MM; PLATE, FIXATION, BONE

Model Number	627456S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Three weeks after surgery is completely unloaded.A load of 1/3 therefrom, 1/2 load after 1 month after the operation, and a stage, the total load in 5 weeks after operation.The plate had broken based on x-ray , the patient leave the hospital 3.5 months after surgery.
Additional Manufacturer Narrative
The reported event that distal anterolateral tibia plate axsos 3 ti for left tibia 6 hole/l127mm was alleged of issue s-12 (implant breakage after surgery) could be confirmed since the device was returned and x-rays were shared for evaluation and matches the alleged failure mode.The device inspection revealed the following: the plate is broken at oblong hole location.The plate is deformed and twisted.The breakage surface under microscope shows a smooth and a mirrored surface (on the longer part of broken plate) and plastically deformed part (on the smaller segment of the broken plate which is the one which underwent most of the stress), which is consistent with an abrupt breakage due to overloading of the plate.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.The clinical evaluation of the medical records provided concluded that ¿the x-ray shows a hypertrophic non-union in the distal third of the tibia.The plate was placed anterolaterally and broke at the transition of the shaft to the metaphyseal part.There are no clear signs of osseous development at the fracture site and there is a clear varus resulting from the asymmetrical load on the plate.Seeing these few details of the case the load has been increased to early in this case.An additional medial plate could have improved the biomechanical characteristics further.¿ the device inspection goes in line with the clinical statement.Based on the investigation, the root cause was attributed to be patient related.The failure was caused by overloading of the plate due to non-union of the bone.Depending on the load application, also, depending on the patient¿s post implant behaviour, on the suitable anatomical reduction, on the kind of bone breakage and depending on the course of bone healing and other factors a implant breakage can rather be classified as anticipated ¿ specifically if one or more contributing issues concurrence with each other.A successful treatment with an implant requires sufficient bone healing during the implantation period.Regarding the outstanding patient data (e.G.Weight, height, potential diseases) it could not be determined if the patient conditions were adequate for the used implant.Implants will be subject of a fatigue fracture if the biomechanical stresses on the implant are too high or not considerably reduced during the period of implantation.During this period there is a race between bony consolidation/fracture healing and implant breakage.Usually a breakage is contributed by one or more deficits, e.G.Insufficient bone healing, product damage.Implant breakage may occur when the material is subjected to repeated loading and unloading resulting fatigue of material.A requirement for successful treatment is that bone healing develops in a sufficient manner that the implant is relieved by load sharing/load transmission over the bone.Otherwise the implant may be subject to a fatigue fracture.Influence factors for the required load reduction are: the type of fracture (e.G.Transverse fracture with sufficient bone support vs.Unstable comminuted fracture w/o sufficient bone contact), the localisation of the fracture (e.G.Diaphysis vs.Metaphysis), the bone quality (e.G.Bone in younger patients vs.Osteoporosis), correct fracture reduction, correct fixation technique (e.G.Correct dimension of the plate, correct positioning of the plate, sufficient length of the plate, sufficient bending of the plate, correct screw placement).Depending on these individual influencing factors the attending physician has to determine the maximum loading and has to limit the weight bearing respectively.This is part of the surgeons' education.Stryker offers labelling of best quality (op-tech, ifu) but stryker cannot grant that all users are skilled in the special field of traumatology and have read the labelling with diligence.A review of the labeling did not indicate any abnormalities.
Event or Problem Description
Three weeks after surgery is completely unloaded.A load of 1/3 therefrom, 1/2 load after 1 month after the operation, and a stage, the total load in 5 weeks after operation.The plate had broken based on x-ray , the patient leave the hospital 3.5 months after surgery.

• Brand Name: DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 TI FOR LEFT TIBIA 6 HOLE / L127MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7531075
• Report Number: 0008031020-2018-00366
• Device Sequence Number: 11150703
• Product Code: HRS
• UDI-Device Identifier: 07613327082012
• UDI-Public: (01)07613327082012
• Combination Product (Y/N): N
• PMA/510(K) Number: K141121
• 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,Followup
• Report Date (Section B): 11/01/2018

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: 05/31/2021
• Device Model Number: 627456S
• Device Catalogue Number: 627456S
• Device Lot Number: V23404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 11/01/2018
• 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: 67 YR