MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 Ø3.5MM / L28MM; PLATE, FIXATION, BONE

Model Number	661428
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	10/21/2022
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
The reported event could be confirmed, although the device was not returned for evaluation, an image was shared which confirms the alleged failure.The device was not returned for evaluation but an image was provided which showed 2 screws to be broken which appears to be cortical screws, but no further information could be determined apart from this.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The provided primary surgery report was insufficient to reach to any conclusion along with the absence of medical records.More information such as patient's medical records like x-rays 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.

• Brand Name: CORTEX SCREW AXSOS 3 Ø3.5MM / L28MM
• 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: 16953264
• Report Number: 0008031020-2023-00205
• Device Sequence Number: 3340056
• Product Code: HRS
• UDI-Device Identifier: 07613252580355
• UDI-Public: 07613252580355
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 07/17/2023

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: 661428
• Device Catalogue Number: 661428
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 07/17/2023
• 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