NA 412.121Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982210661), received between Jun 2, 2025 and Jun 2, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (K000684, K103002); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A LEFT PROXIMAL TIBIA FRACTURE. DURING THE SURGERY, WHEN TRANSFERRING PRODUCTS FROM AN UNCLEANED NURSE TO A CLEANED NURSE, CONNECTION ON ALL THE STERILE TUBES OF THE SCREWS IN THE SCREW SET WAS TIGHT AND DIFFICULT TO DETACH. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125817 ↗
• MalfunctionJun 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A LEFT PROXIMAL TIBIA FRACTURE. DURING THE SURGERY, WHEN TRANSFERRING PRODUCTS FROM AN UNCLEANED NURSE TO A CLEANED NURSE, CONNECTION ON ALL THE STERILE TUBES OF THE SCREWS IN THE SCREW SET WAS TIGHT AND DIFFICULT TO DETACH. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125764 ↗
• MalfunctionJun 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A LEFT PROXIMAL TIBIA FRACTURE. DURING THE SURGERY, WHEN TRANSFERRING PRODUCTS FROM AN UNCLEANED NURSE TO A CLEANED NURSE, CONNECTION ON ALL THE STERILE TUBES OF THE SCREWS IN THE SCREW SET WAS TIGHT AND DIFFICULT TO DETACH. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125613 ↗
• MalfunctionJun 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A LEFT PROXIMAL TIBIA FRACTURE. DURING THE SURGERY, WHEN TRANSFERRING PRODUCTS FROM AN UNCLEANED NURSE TO A CLEANED NURSE, CONNECTION ON ALL THE STERILE TUBES OF THE SCREWS IN THE SCREW SET WAS TIGHT AND DIFFICULT TO DETACH. THE SURGEON AND NURSES WHO WERE THERE COMPLAINED THAT "THIS CONDITION IS ABNORMAL." THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125493 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684, K103002. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,
• Z-2060-2012 · May 22, 2012 · Terminated
  4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu
• Z-2059-2012 · May 22, 2012 · Terminated
  4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu