NA 04.005.422SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982085351), received between Feb 15, 2023 and Feb 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K000089, 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.

• MalfunctionFeb 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF FOR PROXIMAL HUMERUS FRACTURE WITH THE PRODUCTS IN QUESTION. AFTER OPENING THE NAIL, THE SURGEON PERFORMS A DRY CHECK ON THE INSTRUMENT TABLE AND CONFIRMS THAT THE DRILL HAS PASSED THROUGH BEFORE INSERTING THE NAIL INTO THE BODY. HE THEN INSERTED THE GUIDEWIRE FOR BLADE INSERTION AS PER THE PROCEDURE MANUAL, MEASURED AND INSERTED. ONCE IT INTERFERED WITH THE NAIL, IT WAS PULLED BACK AND REINSERTED. AS THE BLADE ADVANCED ALONG THE GUIDEWIRE, THE SCREWS IN QUESTION WERE INSERTED DISTALLY OVER THE DEVICE. WHEN ATTEMPTING TO REMOVE THE DEVICE FOR END CAP INSERTION AFTER DISTAL SCREW INSERTION, IT WAS DISCOVERED THAT THE BLADE AND DISTAL LATERAL STOP SCREWS WERE NOT IN THE NAIL. HE THEN REMOVED THE BLADE AND SCREWS FROM THE BODY AND REINSERTED THE NAIL. THIS TIME HE INSERTED FROM THE DISTAL LATERAL STOP SCREWS AND THE PROXIMAL BLADE, SO THEY WERE INSERTED WITH NO PROBLEM. THE BLADES WERE THE SAME LENGTH, BUT THE DISTAL SCREWS CHANGED LENGTH. THE SCREWS IN QUESTION ARE SCREWS THAT COULD NOT BE INSERTED THROUGH THE DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378957 ↗
• MalfunctionFeb 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF FOR PROXIMAL HUMERUS FRACTURE WITH THE PRODUCTS IN QUESTION. AFTER OPENING THE NAIL, THE SURGEON PERFORMS A DRY CHECK ON THE INSTRUMENT TABLE AND CONFIRMS THAT THE DRILL HAS PASSED THROUGH BEFORE INSERTING THE NAIL INTO THE BODY. HE THEN INSERTED THE GUIDEWIRE FOR BLADE INSERTION AS PER THE PROCEDURE MANUAL, MEASURED AND INSERTED. ONCE IT INTERFERED WITH THE NAIL, IT WAS PULLED BACK AND REINSERTED. AS THE BLADE ADVANCED ALONG THE GUIDEWIRE, THE SCREWS IN QUESTION WERE INSERTED DISTALLY OVER THE DEVICE. WHEN ATTEMPTING TO REMOVE THE DEVICE FOR END CAP INSERTION AFTER DISTAL SCREW INSERTION, IT WAS DISCOVERED THAT THE BLADE AND DISTAL LATERAL STOP SCREWS WERE NOT IN THE NAIL. HE THEN REMOVED THE BLADE AND SCREWS FROM THE BODY AND REINSERTED THE NAIL. THIS TIME HE INSERTED FROM THE DISTAL LATERAL STOP SCREWS AND THE PROXIMAL BLADE, SO THEY WERE INSERTED WITH NO PROBLEM. THE BLADES WERE THE SAME LENGTH, BUT THE DISTAL SCREWS CHANGED LENGTH. THE SCREWS IN QUESTION ARE SCREWS THAT COULD NOT BE INSERTED THROUGH THE DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378953 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000089, K103002. One submission often covers many models, so check the product and lot details in each record.

• 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