MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 Ø3.5MM / L24MM; PLATE, FIXATION, BONE

Model Number	661424
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687); Implant Pain (4561)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: pt broke their right humerus and was compliant to all mobility instructions.Patient went to bed and woke up the following morning and experienced pain in their arm and knew that something was wrong.Went into the hospital, x-rays were taken and it was confirmed that the screw heads were broken within 3-4 weeks post op.The headless screws were left in but the plate and remaining screws were removed.Patient was revised and is having no issues with the plate.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.H3 other text : the headless screws were left in but the plate and remaining screws were removed.
Event or Problem Description
As reported: pt broke their right humerus and was compliant to all mobility instructions.Patient went to bed and woke up the following morning and experienced pain in their arm and knew that something was wrong.Went into the hospital, x-rays were taken and it was confirmed that the screw heads were broken within 3-4 weeks post op.The headless screws were left in but the plate and remaining screws were removed.Patient was revised and is having no issues with the plate.
Additional Manufacturer Narrative
Other text : the headless screws were left in but the plate and remaining screws were removed.

• Brand Name: CORTEX SCREW AXSOS 3 Ø3.5MM / L24MM
• 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: 16939473
• Report Number: 0008031020-2023-00198
• Device Sequence Number: 12266450
• Product Code: HRS
• UDI-Device Identifier: 07613252580331
• UDI-Public: 07613252580331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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: 661424
• Device Catalogue Number: 661424
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 05/18/2023
• 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: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 82 KG