NA 03.010.053Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982067258), received between Sep 28, 2018 and May 9, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A REVISION SURGERY OCCURRED ON (B)(6) 2022. THE REVISION WAS OF HUMERAL EX NAIL AS ORIGINAL SURGERY SHOWED THAT PROXIMAL LOCKING SCREW MISSED THE NAIL. A PROXIMAL SPIRAL BLADE WAS PLACED IN TO STABILIZE. NO HARDWARE WAS REMOVED. THE ORIGINAL IMPLANTS WERE ORIGINALLY IMPLANTED APPROXIMATELY 6 MONTHS PRIOR. EXACT IMPLANT DATE IS UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT STATUS IS UNKNOWN. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR A CONNECTING SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14341466 ↗
• MalfunctionOct 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE: EXPERT HUMERAL NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10726519 ↗
• InjuryApr 20, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REMOVAL SURGERY OF EXPERT HUMERAL NAIL BONE UNION WAS CONFIRMED. DURING THE SURGERY, THE SURGEON COULD NOT CONNECT THE CONNECTING SCREW TO THE NAIL. THE DEVICE COULDN¿T INSERT STRAIGHT TO THE NAIL BECAUSE SOFT PART TISSUE WAS IN THE WAY. THE SURGERY WAS FINISHED WITH THE NAIL REMAINED IN THE PATIENT. THE SURGERY WAS DELAYED BY 100 MINUTES. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9978439 ↗
• MalfunctionSep 28, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, AN UNKNOWN CONNECTING SCREW COULD NOT BE FULLY THREADED ONTO AN UNKNOWN NAIL SO THAT THE INSERTION HANDLE WAS TIGHT AGAINST THE NAIL. THE SURGEON MANUALLY HELD THE INSERTION HANDLE AGAINST THE NAIL WHILE USING THE AIMING ARM TO INSERT THE SPIRAL BLADE. EXTRA WORK AND CARE HAD TO BE TAKEN BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. CONCOMITANT DEVICES: INSERTION HANDLE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), HUMERAL NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), AIMING ARM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), SPIRAL BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A CANNULATED CONNECTING SCREW FOR TITANIUM (TI) CANNULATED HUMERAL NAILS-EXPERT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920167 ↗