MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 FOR RIGHT HUMERUS 5 HOLE / L112MM; PLATE, FIXATION, BONE

Catalog Number	627235
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "screws/plate back-out visible on x-rays.".
Additional Manufacturer Narrative
Corrections: please refer to section b2 and h6 (results code).The reported event could be confirmed although the device was not returned but a few x-rays were shared which confirms the alleged issue.A device inspection was not possible since the affected device was not returned.However, a couple of x-rays were shared which confirms backing out of the plate and some screws.The plate appears to be not fixed on the bone properly.The batch record could not be reviewed because the affected device was not returned, and the lot number communicated was incorrect.No corrective actions are required at this time.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.A clinical opinion from our medical expert was sought with the available information but due to lack of details, a sound clinical assessment couldn¿t be obtained.More information as well as the affected device must be available in order to determine the exact root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "screws/plate back-out visible on x-rays." 5/13/2025 - additional information received from sales rep: the expert told me on the phone that the plate was replaced by a reverse shoulder.

• Brand Name: PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 FOR RIGHT HUMERUS 5 HOLE / L112MM
• 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: 21857755
• Report Number: 0008031020-2025-00732
• Device Sequence Number: 4719454
• Product Code: HRS
• UDI-Device Identifier: 07613327091298
• UDI-Public: 07613327091298
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: 627235
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/23/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other; Required Intervention
• Patient Sex: Unknown