T2 1822-0933SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540197771), received between May 29, 2018 and Aug 9, 2024 — classified as 3 injuries.

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 27, 2018Terminated

   The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.

   Z-2393-2018 · Root cause: Employee error · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Implant Pain

  MAUDE report 19956379 ↗
• InjuryAug 8, 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, IT WAS NOTED THAT PATIENT DIED. NOTE: PATIENT ((B)(6)) DIED INTRA-OPERATIVELY AND IS CURRENTLY PART OF THE OVERDUE GROUP IN ALL VISITS. AS THE DATE OF DEATH IS UNKNOWN, IT COULD NOT BE DETERMINED, IF THE SURGERY WAS EVER FULLY COMPLETED AND THE DEATH OCCURRED A FEW DAYS AFTERWARDS OR THE PATIENT DIED IN THE OPERATING ROOM UPFRONT OF SURGERY COMPLETION.

  Patient problems: Insufficient Information

  MAUDE report 19938132 ↗
• InjuryMay 29, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT'S RIGHT TIBIA WAS REVISED AFTER PATIENT WALKED ON THE ROD AND DISPLACED IT. REP REPORTED THAT HE HAS NO ACCESS TO ANY ADDITIONAL INFORMATION DUE TO NOT BEING ALLOWED ACCESS TO THE HOSPITAL'S PASSWORD-PROTECTED SYSTEMS. REP REPORTED THAT THE NAIL AND 5 SCREWS (3 PROXIMAL, 2 DISTAL) WERE EXPLANTED. HOSPITAL IMPLANT SHEET SHOWS A NAIL AND 6 SCREWS. ADDITIONAL INFO RECEIVED FROM REP'S EMAIL: THERE WAS A SCREW EXCHANGE FROM THE PRIMARY SURGERY DUE TO LENGTH. ONLY 5 SCREWS WERE IMPLANTED. IN INITIAL SURGERY, A 6TH SCREW WAS USED BUT IMMEDIATELY TAKEN OUT. HE DOES NOT KNOW WHICH SCREWS WERE USED AND WHICH ONE WAS NOT USED. THE DISTAL TIBIA DISPLACED NOT THE TIBIAL ROD. ADDITIONAL INFO RECEIVED FROM PHONE CALL WITH REP: REVISION NEEDED BECAUSE "PATIENT WALKED ON LEG WHEN SHOULDN'T HAVE" AND THE BONE MOVED. SURGEON FELT THAT PLATES GAVE A BETTER REDUCTION SO HE SWITCHED FROM THE NAILING SYSTEM TO PLATING.

  Patient problems: No Information

  MAUDE report 7551196 ↗