HOFFMANN 4922-2-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540681010), received between Sep 10, 2018 and Aug 8, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Implant Pain

  MAUDE report 19938324 ↗
• MalfunctionFeb 18, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE ATTACHMENTS COULD NOT BE ATTACHED. REPLACEMENT DEVICES WERE AVAILABLE. ADDITIONALLY REPORTED: THE ATTACHMENT COULD NOT BE PUT INTO THE 5-HOLE PIN HOLDER. THE APPROACHES DID NOT FIT INTO THE "STAR BORE" PROVIDED FOR THEM. THE ORIGINAL H3 7MM T-WRENCHES TO LOOSEN THE SCREWS DURING TESTING WERE USED. THE CUSTOMER NOTICED THE PROBLEMS ALREADY WHEN CONNECTING THE PIN HOLDER WITH THE ATTACHMENTS, SO NO FURTHER ASSEMBLY WAS MADE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9721595 ↗
• MalfunctionSep 10, 2018Loose or Intermittent Connection; Device Slipped

  THE HOFFMANN 3 KICKSTAND FOR AN ANKLE DELTA DFAME CONTINUES TO LOOSEN AND SLIDE OUT. DELTA COUPLINGS WE¿RE FULLY TIGHTENED AND HAS HAPPENED BEFORE PER THE SURGEON (NEVER NOTIFIED OF PRIOR ISSUE) WHEN CONNECTING THE KICKSTAND TO THE TRANSFIXING PIN OR TO THE 11X 350MM CONNECTING RODS. HE FEELS AS IF THE COUPLINGS WERE TIGHT AS POSSIBLE WITH BOTH THE T HANDLE AND WRENCH. ISSUE WAS NOTICED POST SURGERY WHEN THE STABILITY OF THE FRAME DID NOT REMAIN INTACT 2 DAYS POST SURGERY

  Patient problems: No Information

  MAUDE report 7861891 ↗
• MalfunctionSep 10, 2018Loose or Intermittent Connection

  THE HOFFMANN 3 KICKSTAND FOR AN ANKLE DELTA DFAME CONTINUES TO LOOSEN AND SLIDE OUT. DELTA COUPLINGS WE¿RE FULLY TIGHTENED AND HAS HAPPENED BEFORE PER THE SURGEON (NEVER NOTIFIED OF PRIOR ISSUE) WHEN CONNECTING THE KICKSTAND TO THE TRANSFIXING PIN OR TO THE 11X 350MM CONNECTING RODS. HE FEELS AS IF THE COUPLINGS WERE TIGHT AS POSSIBLE WITH BOTH THE T HANDLE AND WRENCH. ISSUE WAS NOTICED POST SURGERY WHEN THE STABILITY OF THE FRAME DID NOT REMAIN INTACT 2 DAYS POST SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7861836 ↗