NA 462.640Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982231918), received between Oct 23, 2018 and Sep 17, 2019 — classified as 2 injuries.

2 other recalls cover devices cleared under the same FDA submission (K992348); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 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 (37) DEVICES. (B)(4).

  Patient problems: No Code Available

  MAUDE report 9079135 ↗
• 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)TI SPIRAL BLADE 40MM FOR TI HUMERAL NAILS. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS 5 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7997452 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K992348. One submission often covers many models, so check the product and lot details in each record.

• Z-1549-2010 · Feb 25, 2010 · Terminated
  7.5mm Ti Solid Humeral Nail 250 mm Sterile Catalog number 462.725S Synthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fract
• Z-1548-2010 · Feb 25, 2010 · Terminated
  7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S Synthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fract