Tracking Array Bracket 109091Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M9461090910), received between Jul 10, 2025 and Jul 10, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K230202, K232802, K241031); they may or may not involve this specific model.

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

• MalfunctionJul 10, 2025Material Fragmentation; Material Fragmentation

  UPON CONCLUSION OF A SUCCESSFULLY COMPLETED ROBOTIC CASE, THE STAFF NOTICED THE PLASTIC FRICTION RING OF THE ARRAY BRACKET WAS DAMAGED AND COMING OFF THE BRACKET DURING DISASSEMBLY AND TRANSFER TO THE BACK TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469879 ↗
• MalfunctionJul 10, 2025Material Fragmentation; Material Fragmentation

  UPON CONCLUSION OF A SUCCESSFULLY COMPLETED ROBOTIC CASE, THE STAFF NOTICED THE PLASTIC FRICTION RING OF THE ARRAY BRACKET WAS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469876 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K230202, K232802, K241031. One submission often covers many models, so check the product and lot details in each record.

• Z-1318-2024 · Feb 12, 2024 · Open, Classified
  Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System