NA 412.113Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982210500), received between Apr 13, 2023 and Apr 13, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionApr 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE IN (B)(4)2023, WHEN THE PRODUCT WAS OPENED, THE CAP CAME OFF THE INNER SLEEVE AND THE SCREW COULD NOT BE REMOVED. THERE WAS A SURGICAL DELAY OF TWO MINUTES, AND THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 34MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16737250 ↗
• MalfunctionApr 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE IN (B)(6) 2023, WHEN THE PRODUCT WAS OPENED, THE CAP CAME OFF THE INNER SLEEVE AND THE SCREW COULD NOT BE REMOVED. THERE WAS A SURGICAL DELAY OF TWO MINUTES, AND THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 34MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16737041 ↗

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