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

Model Number 661424

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687); Implant Pain (4561)

Event Date 04/20/2023

Event Type  Injury  

Event 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 315303620
• Report Number: 0008031020-2023-00198
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613252580331
• UDI-Public: 07613252580331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 82 KG