MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X70MM TL23.5MM; SCREW, FIXATION, BONE

Catalog Number	604670S
Medical Device Problem Codes	Break (1069); Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "one screw out of two was broken during the extraction of azunis 4.0.The broken screw part below the screw head was managed to be removed by shaving the bone of the surrounding area.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned screw could be confirmed based on the catalog and the lot numbers marked.The returned screw is broken into three parts and is highly deformed.The first breakage most probably occurred below the screw's head during the first extraction attempt.The second fracture occurred most probably afterwards, with the screw already highly deformed.The surface of the breakages combined with the extent of the deformation observed give indication of a ductile fracture due to continuous excessive torsional load.Based on investigation, the root cause was attributed to an user related issue.The implant breakage occurred as a result of excessive continuous torsional load applied.It must be noted that the presence of hard bone could also be a cause of the deformation and breakage, as it could have made the extraction more complicated.However, given nothing was indicated by the user and given no x-ray or patient medical records have been received, no statement regarding hard bone could be made.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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "one screw out of two was broken during the extraction of azunis 4.0.The broken screw part below the screw head was managed to be removed by shaving the bone of the surrounding area.".

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X70MM TL23.5MM
• 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: 22962737
• Report Number: 0008031020-2025-01457
• Device Sequence Number: 21241566
• Product Code: HWC
• UDI-Device Identifier: 04546540089946
• UDI-Public: (01)04546540089946(11)230906(17)330831(10)AB9759
• 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: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 604670S
• Device Lot Number: AB9759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• 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: 30 YR
• Patient Sex: Male