MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW IMN SCREWS Ø5X42.5MM; SCREW, FIXATION, BONE

Catalog Number	23605042S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Thrombosis/Thrombus (4440)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "subject: (b)(4).Stryker pegasus study.Deep vein thrombosis acute dvt (left peroneal vein) diagnose dated on (b)(6) 2023 after a few days of worsening leg swelling and pain.Diagnosis via ultrasound.Patient medication changed from heparin to eliquis and discharged same day.By orthopedic f/u on (b)(6) 2023 patient was symptom-free.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned.A review of the device history for the reported lot did not indicate any abnormalities no corrective actions are required at this time.No indications of material manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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: "subject: (b)(6) stryker pegasus study.Deep vein thrombosis acute dvt (left peroneal vein) diagnosed at ed on (b)(6) 2023 after a few days of worsening leg swelling and pain.Diagnosis via ultrasound.Patient medication changed from heparin to eliquis and discharged same day.By orthopedic f/u on (b)(6) 2023 patient was symptom-free.".

• Brand Name: LOCKING SCREW IMN SCREWS Ø5X42.5MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21993357
• Report Number: 0008031020-2025-00877
• Device Sequence Number: 19911320
• Product Code: HWC
• UDI-Device Identifier: 07613327366136
• UDI-Public: 07613327366136
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 23605042S
• Device Lot Number: K152CCD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2023
• 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
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 41 KG