MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR LEFT FEMUR 10 HOLE / L238MM; PLATE, FIXATION, BONE

Model Number	627610S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	12/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the patient complains of sudden pain in the left lower limb in the absence of trauma.On (b)(6) 2023, an x-ray examination revealed a non-union of the supracondylar fracture with breakage of the fixation device.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
As reported: "the patient complains of sudden pain in the left lower limb in the absence of trauma.On (b)(6) 2023, an x-ray examination revealed a non-union of the supracondylar fracture with breakage of the fixation device.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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, like patient history, implantation time or x-rays and as well as the affected device must be available in order to determine the root cause of the reported non-union with subsequent failure of the plate.In this relation following statement of the axsos 3® implants instructions for use can be pointed out: ¿¿ 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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR LEFT FEMUR 10 HOLE / L238MM
• 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: 16314865
• Report Number: 0008031020-2023-00049
• Device Sequence Number: 5759477
• Product Code: HRS
• UDI-Device Identifier: 04546540685681
• UDI-Public: 04546540685681
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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: 627610S
• Device Catalogue Number: 627610S
• Device Lot Number: K28688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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: 78 YR
• Patient Sex: Female