NA 412.116Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982210562), received between Jan 29, 2024 and Jan 29, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS FOR A FRACTURE OF THE PROXIMAL END OF THE TIBIA. THE PTP WAS PLACED ON THE LATERAL. 1 CORTEX SCREW WAS INSERTED IN THE OVAL HOLE AND 4 LOCKING SCREWS WERE INSERTED IN THE JOINT SIDE. THE SURGEON THEN INSERTED A LOCKING SCREW IN THE MOST DISTAL HOLE AND TRIED TO MANUALLY ATTACH A 2.8 MM THREADED DRILL GUIDE TO THE 2ND HOLE FROM THE DISTAL END BUT WAS UNSUCCESSFUL. THE SURGEON THEN MANAGED TO ATTACH THE DRILL GUIDE TO THE 2ND HOLE FROM THE DISTAL END AND INSERTED THE 38MM LOCKING SCREW, BUT TORQUE COULD NOT BE APPLIED. THE SURGEON EXCHANGED THE 38MM LOCKING SCREW WITH THE CORTEX SCREW AND INSERTED IT, BUT TORQUE COULD NOT BE APPLIED AT ALL. THE SURGERY WAS BEING PROCEEDED BY MIPO METHOD. THE SALES REP TOLD THE SURGEON THAT THE 2ND HOLE FROM THE DISTAL END MAY HAVE BEEN DAMAGED. THE SKIN INCISION WAS ENLARGED, AND DIRECT VISUAL INSPECTION REVEALED THAT THE HOLE WAS INDEED BROKEN. SCREW INSERTION INTO THE HOLE IN QUESTION WAS ABANDONED, AN MPT PLATE WAS ADDED MEDIALLY TO FIX THE AFFECTED AREA, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30

  Patient problems: Insufficient Information

  MAUDE report 18595050 ↗

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