NA 412.110Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982210449), received between Sep 15, 2025 and Nov 21, 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.

• MalfunctionNov 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON UNKNOWN DATE THAT TWO SCREWS INVOLVED WOULD NOT PROPERLY LOCK INTO PLATE. THE DRILL BIT INVOLVED WAS FOUND TO BE BENT AND DIDN¿T GO THROUGH LOCKING DRILL GUIDE CORRECTLY. WAS NOT PRESENT FOR CASE WAS TOLD BY CST. NEW SCREWS DRILL BITS WERE USED WITHOUT DELAYS. NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624030 ↗
• MalfunctionNov 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON UNKNOWN DATE THAT TWO SCREWS INVOLVED WOULD NOT PROPERLY LOCK INTO PLATE. THE DRILL BIT INVOLVED WAS FOUND TO BE BENT AND DIDN¿T GO THROUGH LOCKING DRILL GUIDE CORRECTLY. WAS NOT PRESENT FOR CASE WAS TOLD BY CST. NEW SCREWS DRILL BITS WERE USED WITHOUT DELAYS. NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622570 ↗
• MalfunctionSep 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE SURGEON STATED THAT THE DRILL BIT WAS DULL AND THE SCREWS DID NOT LOCK INTO THE PLATE. OTHER DRILL BITS AND SCREWS WERE USED WITH NO FURTHER ISSUES. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23053472 ↗
• MalfunctionSep 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE SURGEON STATED THAT THE DRILL BIT WAS DULL AND THE SCREWS DID NOT LOCK INTO THE PLATE. OTHER DRILL BITS AND SCREWS WERE USED WITH NO FURTHER ISSUES. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052997 ↗

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-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
• 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