EXPert Nail 04.001.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982080769), received between Oct 15, 2018 and Jan 15, 2020 — classified as 2 injuries.

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

2 other recalls cover devices cleared under the same FDA submission (K033071); 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.

• InjuryJan 15, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL AS PLANNED. INITIALLY, THE PATIENT HAD AN IMPLANTATION USING AN EXPERT HUMERAL NAILING SYSTEM IN (B)(6) 2018. AN END CAP WAS SUCCESSFULLY EXPLANTED FROM THE PATIENT AND WAS SENT TO PATHOLOGY FOR EXAMINATION. THERE WAS UNKNOWN TIME OF SURGICAL DELAY. THE PATIENT WAS IN GOOD HEALTH. CONCOMITANT DEVICE REPORTED: UNK - NAILS: EXPERT HUMERAL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN SPIRAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4) . RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Code Available

  MAUDE report 9592184 ↗
• InjuryOct 15, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING IMPLANTATION OF A TITANIUM HUMERAL NAIL EX, THE SURGEON DECIDED TO USE A TITANIUM END CAP AND PLACED IN THE PROXIMAL TIP OF THE NAIL. DURING THE IMPLANTATION PROCEDURE, THE END CAP WOULD NOT ADVANCE TO THE FULL SITTING. WHEN THE SURGEON DECIDED TO REMOVE IT AND RE-IMPLANT THE END CAP, THE IMPLANT WOULD NOT COME OUT. EFFORTS WERE MADE WITH SEVERAL INSTRUMENTS AND THE AID OF T25 SCREW DRIVER BUT THE LOCATION AND SPACE WITHIN THE HUMERAL HEAD MADE IT IMPOSSIBLE TO EXTRACT THE END CAP. AFTER AN HOUR OR SO OF EFFORTS, THE SURGEON DECIDED TO STOP THE EXTRACTION AND LEAVE THE IMPLANTED END CAP IN THE PATIENT. THE END CAP IS ABOUT 2-3MM PROUD AT THE SUPERIOR ASPECT OF THE HUMERAL HEAD. THERE WAS A SURGICAL DELAY OF ONE HOUR OR MORE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TITANIUM HUMERAL NAIL EX (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) . THIS REPORT IS FOR ONE (1) TI END CAP T25 STRDRV 10MM EXT HUMERAL NAIL-EX SPIRAL BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7965354 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033071. One submission often covers many models, so check the product and lot details in each record.

• Z-0407-2014 · Jul 30, 2013 · Terminated
  Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.