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

Model Number	627646
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Hip Fracture (2349)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "refracture of mid shaft right femoral #& fracture of stryker axsos 3 distal femoral plate.
Event or Problem Description
As reported: "refracture of mid shaft right femoral & fracture of stryker axsos 3 distal femoral plate.
Additional Manufacturer Narrative
The reported event could be confirmed, since the x-rays and operative notes were provided for evaluation and matches the alleged failure mode.A device inspection was not possible since the affected device was not returned for evaluation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Formal medical opinion was sought from an experienced independent medical expert as below; ¿there is no implant breakage visible on the x-ray.What we can see is a failure of the implant with clearly visible loosening of the most proximal of the distal screws and the loss of reduction at the fracture site with a significant dislocation of the distal fragment.From the operative notes one would suggest that the loosening of the screw and the loss of reduction took place with one single sudden incident, because the patient was not able to put weight on the foot anymore.An underlying cause could be, that in my opinion the distance between the distal screw and the fracture site is chosen too long.To allow for some movement at the fracture site even in angular stable locking you may choose a screw position in a distance to the fracture, but in this case it looks as if it is more or less 10cm and that is probably to much.¿ 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.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 TI 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12446303
• Report Number: 0008031020-2021-00404
• Device Sequence Number: 14336755
• Product Code: HRS
• UDI-Device Identifier: 07613252579694
• UDI-Public: 07613252579694
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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: 627646
• Device Catalogue Number: 627646
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 101 KG