MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR RIGHT FEMUR 16 HOLE / L343MM; PLATE, FIXATION, BONE

Model Number	627646
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/22/2023
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: "axsos 3 distal femur broke in less than 2 months after surgery." this resulted in a revision surgery.
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 has shown that the plate is broken apart in the middle of the shaft at a locking hole.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 especially on the right side of the fracture face, starting on the top corners of the hole.There are shiny surfaces on the bottom side of 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.The thread flanks of the locking thread are damaged, which indicates that this hole was occupied with a locking screw, this can also be confirmed on the received x-rays.The relevant dimensions were verified during the investigation and no deviation from the specification could be detected.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.The complaint was forwarded to medical affairs for review with following feedback: "there is an oblique fracture visible in two planes.The fracture has been stabilized with two cerclages and a plate.The plate in the midportion has been fixed with a distance of 1,5cm to the femur, which is in an angular stable implant technically possible.However, it is from the provided information not clear why the plate was implanted with this distance, while the revision with another plate was made without such distance.Based on the available information it can be said that this occurrence is mainly patient related.The distance between the plate and the femur may have played a certain role as this allows more movement at the fracture site with the potential consequence of delayed or non-union.".No product related issue could be detected.Based on investigation, the root cause was attributed to a patient related issue, which did lead to a fatigue failure of the plate.No indications of material, manufacturing or design related problems were found during the investigation.
Event or Problem Description
As reported: "axsos 3 distal femur broke in less than 2 months after surgery.".This resulted in a revision surgery.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR RIGHT FEMUR 16 HOLE / L343MM
• 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: 16494592
• Report Number: 0008031020-2023-00107
• Device Sequence Number: 17702167
• Product Code: HRS
• UDI-Device Identifier: 07613252579694
• UDI-Public: 07613252579694
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 05/02/2023

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 Model Number: 627646
• Device Catalogue Number: 627646
• Device Lot Number: H49070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 65 KG