NA 04.005.412Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982085245), received between Oct 23, 2018 and Sep 29, 2020 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A REVISION SURGERY OCCURRED DUE TO FRACTURE DISPLACEMENT AND IMPAIRED HEALING. NO IMPLANT MALFUNCTIONS OCCURRED. ALL HARDWARE WAS REMOVED. IT IS UNKNOWN WHAT IMPLANTS THE PATIENT WAS REVISED TO. THE ORIGINAL SURGERY AND IMPLANTATION WITH THE MULTILOC HUMERAL NAILING SYSTEM OCCURRED ON (B)(6) 2020. THE PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 10600314 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, IT WAS FOUND OUT THAT AN UNKNOWN HUMERAL NAIL SET DO NOT HAVE AN UNKNOWN CADDY WITH AN UNKNOWN BLADES, UNKNOWN 4.0 TITANIUM SCREWS AND UNKNOWN END CAPS. ORIGINALLY, THE SALES CONSULTANT GETS THE SET AND THERE¿S GOING TO BE A TOTE WITH IMPLANTS FOR BLADES AND SCREWS AND END CAPS. THE SALES CONSULTANT CALLED THE FSL AND EVENTUALLY DISCOVERED THAT THERE WAS SUPPOSED TO BE A CADDY INSIDE THE SET. THE SALES CONSULTANT THEN GO AND DRIVE TO ANOTHER HOSPITAL AND RETURN WITH A TOTE FOR SAID IMPLANTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED; HOWEVER, THE PATIENT SPENT AN EXTRA 100 MINUTES UNDER ANESTHESIA. ALSO, THE END CAP AVAILABLE FROM THE OTHER HOSPITAL WAS NOT THE CORRECT SIZE, SO IT PROTRUDED FROM THE PATIENT¿S HUMERAL HEAD. RE-OPERATION IS MOST LIKELY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES THIRTY-EIGHT (38) DEVICES. THIS IS REPORT 3 FOR 10 (B)(4). OTHER DEVICES WAS INCLUDED WITH RELATED INCIDENTS: (B)(4).

  Patient problems: No Code Available

  MAUDE report 9072686 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH ONE (1) TITANIUM END CAP T25 STARDRIVE, ONE (1) TITANIUM DISTAL LOCKING SCREW, ONE (1) TITANIUM CANNULATED HUMERAL NAIL-EX, STERILE, ONE (1) 38MM TITANIUM LOCKING SCREW AND ONE (1) TITANIUM SPIRAL BLADE ON AN OPEN REDUCTION INTERNAL FIXATION (ORIF) DUE TO PROXIMAL HUMERAL FRACTURE. AFTER THE INSERTION OF THE TITANIUM CANNULATED HUMERAL NAIL-EX THE BONE FAILED AROUND THE IMPLANT. THE SURGEON REMOVED THE TITANIUM END CAP T25 STARDRIVE, TITANIUM LOCKING SCREW AND THE TITANIUM SPIRAL BLADE AND RE-REDUCED THE HUMERAL HEAD ON TOP OF THE NAIL. THE ONLY IMPLANTS THAT REMAINED IN THE PATIENT WERE THE TITANIUM CANNULATED HUMERAL NAIL-EX AND THE TITANIUM DISTAL LOCKING SCREW. THE SURGEON INDICATED THAT THERE WAS CONCERN WITH THE PATIENTS BONE QUALITY AND POSSIBLY BONE CANCER. THERE WAS A NOTED ABNORMALITY ON THE X-RAY AND A CULTURE WAS TAKEN FROM THE POSSIBLE MALIGNANT TUMOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY. THIS REPORT IS FOR (1) 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 22MM FOR IM NAILS THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS 2 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7997422 ↗

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-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