MAUDE Adverse Event Report: STRYKER GMBH ASNIS III CANNULATED SCREW, PARTIALLY THREADED D4.0X44MM TL15MM; SCREW, FIXATION, BONE

Catalog Number	604644S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "when inserting the screw through the guide pin, the surgeon felt a firm resistance.Continuing to insert it, the screwdriver began to slip halfway through.Upon removing the guide pin, the screw also came out.Upon inspection, it was found that the screw was broken, and the remaining broken screw fragment could not be removed from the patient's body.Thus, the surgery was completed while the screw fragment was left in the patient's body.".

• Brand Name: ASNIS III CANNULATED SCREW, PARTIALLY THREADED D4.0X44MM TL15MM
• 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: 24676896
• Report Number: 0008031020-2026-00471
• Device Sequence Number: 10139890
• Product Code: HWC
• UDI-Device Identifier: 04546540089809
• UDI-Public: (01)04546540089809(11)230311(10)AA0190
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K220319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 604644S
• Device Lot Number: AA0190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2023
• 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
• Patient Age: 77 YR
• Patient Sex: Male