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

Catalog Number	627610
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "an axsos 3 distal lateral femur plate was implanted in the patient at the end of march 2023 and fractured in the patient in the week of (b)(6) 2023.The plate was removed on (b)(6) 2023 and a t2 alpha femur retrograde nail was inserted.".
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.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "an axsos 3 distal lateral femur plate was implanted in the patient at the end of (b)(6) 2023 and fractured in the patient in the week of (b)(6) 2023.The plate was removed on (b)(6) 2023 and a t2 alpha femur retrograde nail was inserted.".
Event or Problem Description
As reported: "an axsos 3 distal lateral femur plate was implanted in the patient at the end of (b)(6) 2023 and fractured in the patient in the week of (b)(6) 2023.The plate was removed on (b)(6) 2023 and a t2 alpha femur retrograde nail was inserted.".
Additional Manufacturer Narrative
Correction - please refer to d9/h3, h6 (method, results & conclusion codes).The reported event could be confirmed based on the inspection performed on the returned plate.The device inspection revealed the following: the identification of the returned plate could be confirmed based on the catalog # and lot # marked.The returned implant is broken in two in the middle, at the 6th locking hole.Both parts have been returned for inspection.Microscopic images of the breakage surface give indication that the fracture originated in the anterior side of the plate.The presence of rest lines give evidence of a fatigue fracture.The shiny areas observed are a result of friction between the plate parts during the breakage.A secondary fatigue fracture could also be observed in the posterior side of the plate.Signs of a rapid fracture ("catastrophic rupture") on the posterior side also give indication that the plate broke suddenly under high load.The scratches observed on the implant's surface occurred most probably during the explantation and are most probably not directly related to the breakage.Dimensional inspection showed the plate to be according to specifications.Despite the inspection of the plate, it was not possible to determine the exact root cause of the implant's failure.X-rays and the medical records of the patient would have been necessary.Nonetheless, based on the inspection of the implant and of its manufacturing documents, any manufacturing related issue could be discarded.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 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: 18247732
• Report Number: 0008031020-2023-00420
• Device Sequence Number: 20483202
• Product Code: HRS
• UDI-Device Identifier: 07613252579571
• UDI-Public: 07613252579571
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2024

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: 627610
• Device Lot Number: J21707
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 01/10/2024; 10/08/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/31/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2015
• 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: Female