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

Model Number	627486S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Necrosis (1971); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "plate fracture due to prolonged healing.The first surgery (osteosynthesis for right distal tibia) was performed on (b)(6) 2022.Although the actual date of occurrence is unknown, skin necrosis was found after the surgery.Necrosis gradually spread to the surrounding area and required skin grafting.After that, the revision surgery was performed on (b)(6) 2023 as the implanted plate was broken.Whole plate was removed, external fixation was performed, defect site was filled with cement, in which antibiotic was mixed, and the revision surgery was completed.The operator told that he did not know when the infection occurred or whether the patient was following the permitted range of post-treatment.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned; therefore, an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "plate fracture due to prolonged healing.The first surgery (osteosynthesis for right distal tibia) was performed on (b)(6) 2022.Although the actual date of occurrence is unknown, skin necrosis was found after the surgery.Necrosis gradually spread to the surrounding area and required skin grafting.After that, the revision surgery was performed on (b)(6) 2023 as the implanted plate was broken.Whole plate was removed, external fixation was performed, defect site was filled with cement, in which antibiotic was mixed, and the revision surgery was completed.The operator told that he did not know when the infection occurred or whether the patient was following the permitted range of post-treatment.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Based on the information provided for the investigation, the root cause was attributed to a patient condition related issue.The failure was most probably caused by the reported delayed union of the bone and necrosis.However, the device was not returned and no other information about the patient, the patient's postoperative activity or x-rays were received.Therefore, it was not possible to determine if an additional factor, other than the reported delayed union and necrosis, could have contributed to the implant failure.As a reminder, the instructions for use clearly state that: " ¿ these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason post-operative instructions and warnings to patients are extremely important.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation.[.] 13 adverse events and adverse effects: complications that can occur as a consequence of osteosynthesis of bones and bone fragments using large fragment plating systems may include the following clinical signs and symptoms.Proximal and distal tibia plates: loss of range of motion (joint stiffness), delayed union, malunion, pain/implant pain (local discomfort, tenderness, soft tissue irritation), infection (post-operative wound infection, sepsis/septic arthritis, osteomyelitis, and pneumonia), non-union, post-traumatic arthritis, unequal limb length, soft tissue injury, nerve damage, hematoma, thrombosis (infarction/thromboembolism), impaired healing (wound complications, delayed healing), necrosis (skin), skin inflammation/irritation, wound dehiscence, compartment syndrome, complex regional pain syndrome (crps), and hypersensitivity/allergic reaction." 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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 FOR RIGHT TIBIA 6 HOLE / L127MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16335434
• Report Number: 0008031020-2023-00080
• Device Sequence Number: 6845084
• Product Code: HRS
• UDI-Device Identifier: 07613327082203
• UDI-Public: 07613327082203
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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: 06/30/2024
• Device Model Number: 627486S
• Device Catalogue Number: 627486S
• Device Lot Number: D37044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male