MAUDE Adverse Event Report: STRYKER GMBH ASNIS III CANNULATED SCREW, PARTIALLY THREADED D5.0X48MM TL16MM; SCREW, FIXATION, BONE

Catalog Number	601648S
Medical Device Problem Codes	Off-Label Use (1494); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "a bone cut (dto) was performed using phito plates and asnis screw on (b)(6) 2025.However, flange lifting was observed postoperatively, necessitating a second surgery.Revision surgery was performed on (b)(6) 2026.Inserted asnis screw was removed and 3 new asnis screws were inserted for fixation.".
Event or Problem Description
As reported: "a bone cut (dto) was performed using phito plates and asnis screw on (b)(6) 2025.However flange lifting was observed postoperatively, necessitating a second surgery.Revision surgery was performed on january 13, 2026.Inserted asnis screw was removed and 3 new asnis screws were inserted for fixation.".
Additional Manufacturer Narrative
The reported event could be confirmed based on the provided documentation.The provided x-rays and information were forwarded to medical affairs, with the following review: "the contributing factors might be too much force on the osteotomy and tuberositas tibiae area, which one screw could not hold.The movement of the screw, where there is the darker area around it, indicates the loosening.Overall, the exact root cause cannot be defined.Implant loosening is, in general, multifactorial.The location and pattern of the fracture/osteotomy, biology, and the technical aspects of the surgical procedure have contributed to the event.Furthermore, patient activity levels post-op may also have contributed to an inadequate load distribution and, therefore, the loosening of the implants." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation, the root cause was attributed to a combination of user and patient condition related issue.If more information is provided, the case will be reassessed.

• Brand Name: ASNIS III CANNULATED SCREW, PARTIALLY THREADED D5.0X48MM TL16MM
• 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: 24278374
• Report Number: 0008031020-2026-00123
• Device Sequence Number: 18632557
• Product Code: HWC
• UDI-Device Identifier: 04546540086440
• UDI-Public: (01)04546540086440(17)330630(10)AB4269
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K220319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: 601648S
• Device Lot Number: AB4269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• 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: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 78 KG