MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR RIGHT FEMUR 12 HOLE / L274MM; PLATE, FIXATION, BONE

Catalog Number	627642
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924)
Date of Event	10/23/2023
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
It was reported that the patient underwent surgery on 04/08.On 23/10/23, she stumbled at home (low inertia trauma) and the femoral plate broke.She had to return to the operating theatre on (b)(6) 2023.
Additional Manufacturer Narrative
The reported event could be confirmed based on the inspection performed.The device inspection revealed the following: the identification of the returned plate was confirmed based on the catalog # and lot # marked.The reported breakage of the implant could be confirmed, both parts were returned for investigation.Microscopic images show the presence of rest lines on the breakage surface of the posterior side of the plate.This gives evidence of a fatigue fracture.A secondary fatigue fracture could also be observed on the anterior side of the plate.Signs of a rapide fracture ("catastrophic rupture") on the anterior side give indication that the plate broke suddenly under high load, most probably a result of the patient stumbling.The shiny areas are most probably a result of the friction between both parts following the breakage.The scratch marks observed on the plate may have occurred during the explantation and are most probably not a direct result of the fracture.Dimensional inspection has shown the device to be compliant according to the specifications.Based on investigation, the root cause was attributed to a patient related issue.The failure of the implant could be linked to patient's stumble, which led to excessive loading being applied to the plate.It must be noted that the fatigue fractures, that appeared most probably prior to the stumble, could be identified as the primary mode of breakage.Due to the absence of x-rays, it was not possible to make any statement regarding the condition of the patient's bone and it's influence on the fatigue fractures.It must be noted, however, that no sign of usage error (ex: misaligned drilling) that could have generated the fatigue fractures was observed.As a reminder, the instructions for use clearly state that: 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 nonunion and that the device has a finite expected service life and may need to be removed at some time in the future.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." 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 more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the patient underwent surgery on (b)(6).On (b)(6) 2023, she stumbled at home (low inertia trauma) and the femoral plate broke.She had to return to the operating theatre on (b)(6) 2023.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR RIGHT FEMUR 12 HOLE / L274MM
• 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: 18191851
• Report Number: 0008031020-2023-00403
• Device Sequence Number: 20649134
• Product Code: HRS
• UDI-Device Identifier: 07613252579670
• UDI-Public: 07613252579670
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K222381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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 Catalogue Number: 627642
• Device Lot Number: K62247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 48 KG