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

Catalog Number	627616
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924)
Date of Event	04/05/2024
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 had a fracture on a knee prosthesis in (b)(6) 2023 operated with an axsos femur plate.He fell while gardening and broke his axsos plate.The patient was revised with a new axsos femur plate and bone graft.".
Additional Manufacturer Narrative
Correction: please refer to d3.The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The received distal lateral femur plate was visually inspected in which we can see scratch marks on the plate, three locking screws stuck in the plate having their head damaged and the plate broken into two fragments.Both the broken pieces were visually inspected which shows the signs of a breakage in a fatigue manner.It is evident by a smooth topography.Lines of rest are visible planes of breakage starting on the top corners of the hole.We can also see the shiny surface on both the aircraft of breakage which indicates that both the pieces rubbed with each other after breakage.On one end of the proximal part, we can see signs of instantaneous breakage available which was caused due to excessive application of force from the sudden fall.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.In this relation following statement of the axsos 3 implants instructions for use 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.¿ (original statements) 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 and brittle fracture was caused due to sudden fall.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that "the patient had a fracture on a knee prosthesis in (b)(6) 2023 operated with an axsos femur plate.He fell while gardening and broke his axsos plate.The patient was revised with a new axsos femur plate and bone graft.".

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR LEFT 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: 19203644
• Report Number: 0008031020-2024-00175
• Device Sequence Number: 20859738
• Product Code: HRS
• UDI-Device Identifier: 07613252579601
• UDI-Public: 07613252579601
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: 627616
• Device Lot Number: AB8697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 75 KG