T2 1822-1136SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540198051), received between Aug 9, 2024 and Aug 22, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Jam” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2024Mechanical Jam; Mechanical Jam

  THE SALES REP REPORTED THAT: "DURING THE OPERATION, THE SURGICAL TEAM WAS UNABLE TO COMPLETE THE PROCEDURE DUE TO A TECHNICAL PROBLEM WITH THE ANCILLARY PARTS. AFTER REAMING THE PATIENT'S TIBIA AND IDENTIFYING THE IMPLANT TO BE PLACED, THE OPERATORS WERE UNABLE TO CONTINUE THE PROCEDURE DUE TO A PROBLEM WITH THE ASSEMBLY AND DISASSEMBLY OF THE BOLT, NAIL HOLDER AND IMPLANT. THE BOLT AND NAIL HOLDER REMAINED ATTACHED, MAKING IT IMPOSSIBLE TO DISMANTLE THE IMPLANT ONCE THE PROCEDURE HAD BEEN COMPLETED. FOR SAFETY REASONS, THE OPERATORS PREFERRED NOT TO IMPLANT THE IMPLANT AND TO POSTPONE THE OPERATION TO A LATER DATE. INTERVENTION POSTPONED TO ON (B)(6) INSTEAD OF ON (B)(6). THE OPERATION WAS CARRIED OUT BY AN EXPERIENCED SURGICAL TEAM. THE ¿RECOVERY¿ OPERATION TOOK PLACE IN THE PRESENCE OF THE LOCAL SALES MANAGER AND WENT SMOOTHLY. THE FAULTY EQUIPMENT WAS TAKEN BACK BY THE SALES REPRESENTATIVE FOR EXPERT EXAMINATION."

  Patient problems: Insufficient Information

  MAUDE report 20039563 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, MAL-UNION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Malunion of Bone

  MAUDE report 19956291 ↗