MAUDE Adverse Event Report: STRYKER GMBH DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 FOR LEFT TIBIA 14 HOLE / L229MM; PLATE, FIXATION, BONE

Model Number	627464S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/16/2022
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
As reported: "the device, implanted in (b)(6) 2022 on a patient suffering from pseudo-arthrosis of the left tibia, broke".
Event or Problem Description
As reported: "the device, implanted in (b)(6) 2022 on a patient suffering from pseudo-arthrosis of the left tibia, broke".
Additional Manufacturer Narrative
The reported event could be confirmed, since the plate is broken apart as complained.The device inspection revealed the following: the visual inspection shows that the plate is broken apart at the third shaft locking hole on the distal side of the plate.There are scratches all over the plate, but afterwards it cannot be defined if these damages were caused during insertion or extraction.The microscopic examination of the fracture surface reveals the fracture to be a typical fatigue fracture evident by a smooth topography.Lines of rest are visible on both sides of the fracture.There are shiny surfaces on both fracture faces, which indicates that the fragments rubbed against each other after the breakage.The rest of the fracture face has the typical view of a fatigue fracture with an uniform fine-grained texture.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.No product related issue could be detected.There was no additional information, like x-rays, operation reports, implant date, patient history or activity, provided.Therefore the root cause of the breakage cannot be defined.The evaluation of the plate has shown that fatigue did lead to the breakage of the device.In this relation following statement of the axsos 3 implants instructions for use (v15300 rev.Aa, 04-2021) can be mentioned: ¿the implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.Regular postoperative examinations (e.G.X-ray checks) are advisable" if more information is provided, the case will be reassessed.

• Brand Name: DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 FOR LEFT TIBIA 14 HOLE / L229MM
• 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: 16223523
• Report Number: 0008031020-2023-00027
• Device Sequence Number: 5542711
• Product Code: HRS
• UDI-Device Identifier: 07613327081923
• UDI-Public: 07613327081923
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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: 06/30/2026
• Device Model Number: 627464S
• Device Catalogue Number: 627464S
• Device Lot Number: H44057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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: 61 YR
• Patient Sex: Unknown