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

Catalog Number	627646S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the rep: "raqa purpose: surgeon would like the stryker engineers to take a look at a removed plate once decontaminated and returned.Patient info: has a hip replacement, total knee replacement and axsos 5mm dlf with dall miles cables.Surgeon reports patient had hip replacement and knee replacement previously.Patient then fell over in (b)(6) this year and fractured the femur, requiring an axsos dlf plate.More recently, patient has fallen again and subsequently required today¿s surgery focus item: axsos 3 5mm system, distal lateral femoral plate, titanium.16 hole.Shaft is affected at approx.4th hole above the oblong hole.Plate insertion case date: (b)(6) 2025.Location: (b)(6) hospital.Removal case date: (b)(6) 2025.Location: (b)(6) hospital, theatre 11.Time: approx.1pm to 6:30pm.Purpose of case today: remove affected axsos plate and screws, insert an alpha retrograde nail and a new axsos dlf 16 hole.Kits used today: axsos 3 5mm, t2 alpha retrograde indication, t2 alpha basic imn.All consigned instrument kits (not loaned).".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed with the provided image in which we can see that the plate is broken which confirms the event.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported by the rep: "raqa purpose: surgeon would like the stryker engineers to take a look at a removed plate once decontaminated and returned.Patient info: has a hip replacement, total knee replacement and axsos 5mm dlf with dall miles cables.Surgeon reports patient had hip replacement and knee replacement previously.Patient then fell over in march this year and fractured the femur, requiring an axsos dlf plate.More recently, patient has fallen again and subsequently required today¿s surgery focus item: axsos 3 5mm system, distal lateral femoral plate, titanium.16 hole.Shaft is affected at approx.4th hole above the oblong hole.Plate insertion case date: (b)(6) 2025 location: (b)(6).Removal case date: (b)(6) 2025 location: (b)(6) time: approx.1pm to 6:30pm.Purpose of case today: remove affected axsos plate and screws, insert an alpha retrograde nail and a new axsos dlf 16 hole.Kits used today: axsos 3 5mm, t2 alpha retrograde indication, t2 alpha basic imn.All consigned instrument kits (not loaned).".

• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22287495
• Report Number: 0008031020-2025-00974
• Device Sequence Number: 8374287
• Product Code: HRS
• UDI-Device Identifier: 04546540685780
• UDI-Public: 04546540685780
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: 627646S
• Device Lot Number: K46386
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2022
• 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 Sex: Unknown