MAUDE Adverse Event Report: STRYKER GMBH IMN SCREWS - LOCKING SCREW D5X37.5MM; SCREW, FIXATION, BONE

Catalog Number	23605037S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Insufficient Information (4580)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "imn femur was done on (b)(6) 2025.The doctor saw the patient in the clinic on (b)(6) 2026 and reported that the a/r nail in this patient was bending after seeing him in clinic this week.He also reported that one of the locking screws is also broken.".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "imn femur was done on (b)(6) 2025.The doctor saw the patient in the clinic on (b)(6) 2026 and reported that the a/r nail in this patient was bending after seeing him in clinic this week.He also reported that one of the locking screws is also broken.".
Additional Manufacturer Narrative
The reported event could be confirmed with the provided x-ray images in which we can see that the nail is slightly bent and one of the distal screws is broken.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design-related problems were found during the investigation.Hcp opinion on provided x rays: "the event appears consistent with a nonunion scenario associated with inadequate fracture-site stability.The hcp indicated that the fracture pattern likely contributed to reduced construct stability, resulting in continuous motion at the fracture site.This persistent instability may have contributed to screw breakage and subsequent increased loading on the remaining fixation components, potentially leading to nail bending.Overall, the event appears multifactorial, with contributing factors including fracture characteristics, biological factors, surgical technique, and postoperative loading/activity." based on the limited information available, the root cause of the reported event cannot be defined as this is often muti-factorial.The location of the fracture and the technical aspects of the surgical procedure could have contributed to the event.Furthermore, patient condition and activity levels post-op may also have contributed to an inadequate load distribution, and therefore the breakage of the implant.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: IMN SCREWS - LOCKING SCREW D5X37.5MM
• Common Device Name: SCREW, 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24669651
• Report Number: 0008031020-2026-00451
• Device Sequence Number: 9227354
• Product Code: HWC
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K251400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: 23605037S
• Device Lot Number: K149CA1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2025
• 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: 21 YR
• Patient Sex: Unknown