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

Catalog Number	627610S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/20/2023
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
As reported: "fracture of a femoral plate 2 months after surgery".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The microscopic examination of the fracture surface reveals the breakage to be a typical fatigue pattern evident by a smooth topography.Lines of rest are visible on both sides of the fracture.There are shiny surfaces on the broken faces, which indicates that the fragments rubbed against each other after the breakage.The rest of the breakage face has the typical view of breakage in a fatigued manner with a uniform fine-grained texture.With the available radiograph, a formal medical opinion was sought: "there are some suggestive signs of the shortening after the plate breakage, the hypertrophic callus formation, and the remaining fracture line, all may point to a non-union." 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.Based on the investigation, the root cause was attributed to a combination of user and patient-related factors.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "fracture of a femoral plate 2 months after surgery".
Additional Manufacturer Narrative
Please note the corrections to d1, d4 catalog # and gtin.
Event or Problem Description
As reported: "fracture of a femoral plate 2 months after surgery".

• 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: 17901236
• Report Number: 0008031020-2023-00353
• Device Sequence Number: 3366820
• Product Code: HRS
• UDI-Device Identifier: 04546540685681
• UDI-Public: 04546540685681
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 12/07/2023

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 Catalogue Number: 627610S
• Device Lot Number: K78560
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 10/30/2023; 11/30/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/22/2023; 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 125 KG