NA 03.010.055Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982067272), received between Feb 21, 2018 and May 9, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 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 3 OF 3 FOR (B)(4). THIS REPORT IS FOR A SPIRAL BLADE AIMING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14341715 ↗
• MalfunctionMar 30, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CUSTOMER RETAINING THE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9898047 ↗
• MalfunctionApr 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO PUT THE SPIRAL BLADE INSERTER (WITH THE SPIRAL BLADE ATTACHED) THROUGH THE SPIRAL BLADE HOLE IN THE AIMING ARM. THE BLADE WENT THROUGH THE HOLE BUT THE INSERTER WOULD NOT. THE DIAMETER OF THE INSERTER WAS TOO WIDE TO FIT INSIDE THE AIMING ARM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. CONCOMITANT MEDICAL PRODUCTS REPORTED: UNKNOWN SPIRAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SPIRAL BLADE AIMING ARM FOR TI CANNULATED HUMERAL NAILS-EX. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8493902 ↗
• InjuryDec 20, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR THE LEFT HUMERAL DIAPHYSEAL FRACTURE WAS PERFORMED WITH AN EXPERT HUMERAL NAILING SYSTEM. THE SURGEON TRIED TO INSERT THE SPIRAL BLADE IN ACCORDANCE WITH THE SURGICAL TECHNIQUE BUT THE BLADE INTERFERED WITH THE ANTERIOR SIDE OF THE NAIL. THIS WAS CONFIRMED BY X-RAY ANALYSIS. THE SURGEON REMOVED THE BLADE FROM THE PATIENT AND FOUND IT WAS BROKEN. ANOTHER BLADE OF DIFFERENT LENGTH WAS INSERTED SUCCESSFULLY BY ADJUSTING THE INSERTER TO FACE THE ANTERIOR WITHIN THE AIMING ARM. THE SURGERY WAS DELAYED LESS THAN 30 MINUTES. ADVERSE CONSEQUENCE WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) SPIRAL BLADE AIMING ARM FOR TI CANNULATED HUMERAL NAILS-EX. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8185837 ↗
• MalfunctionJul 12, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING A DEMONSTRATION AT THE HOSPITAL, THE SALES CONSULTANT WAS USING INSTRUMENTS FROM TWO TRAYS. IT WAS NOTICED THAT BOTH SPIRAL BLADE INSERTER FROM EACH TRAY AND BOTH AIMING ARMS FROM EACH TRAY APPEARED TO HAVE ALIGNMENT ISSUES. THE SPIRAL BLADE INSERTER WOULD NOT ALIGN AND GO THROUGH THE SPIRAL BLADE AIMING ARM. ALL FOUR DEVICES WERE NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPIRAL BLADE AIMING ARM FOR TI CANNULATED HUMERAL NAILS-EX.. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7682478 ↗
• MalfunctionJul 12, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING A DEMONSTRATION AT THE HOSPITAL, THE SALES CONSULTANT WAS USING INSTRUMENTS FROM TWO TRAYS. IT WAS NOTICED THAT BOTH SPIRAL BLADE INSERTER FROM EACH TRAY AND BOTH AIMING ARMS FROM EACH TRAY APPEARED TO HAVE ALIGNMENT ISSUES. THE SPIRAL BLADE INSERTER WOULD NOT ALIGN AND GO THROUGH THE SPIRAL BLADE AIMING ARM. ALL FOUR DEVICES WERE NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPIRAL BLADE AIMING ARM FOR TI CANNULATED HUMERAL NAILS-EX. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7682441 ↗
• MalfunctionFeb 21, 2018Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CASE WAS DONE ON (B)(6) 2017 AND THERE WAS AN ISSUE WITH DRILL SLEEVES JAMMING. THE SURGEON INSERTED A SHORT NAIL, SPIRAL BLADE AND SCREW IN THE PROXIMAL LOCKING HOLE. DURING THE PROCEDURE, THE DOCTOR WAS SHAKING THE JIG UP AND DOWN WHILE IT ON THE NAIL; THE DRILL SLEEVES WERE FILLED WITH TISSUE AND GOT JAMMED. THE DOCTOR WAS USING THE 3.2 DRILL SLEEVES FOR DISTAL LOCKING, HE WENT TO REMOVE THE TROCAR AND IT WAS VERY TIGHT AND DID NOT WANT TO COME OUT. THE DRILL SLEEVE AND TROCAR WAS STUCK TOGETHER. WHEN THEY WERE ABLE TO GET THE TROCAR COMBINATION DRILL SLEEVES OUT, THERE WAS A LOT OF TISSUE IN THE TIP. IT WAS CLEANED WITH PEROXIDE TO RELEASE THE TISSUE THEY WERE TAKEN OUT AND WASHED. HE THEN CONTINUED TO PUT THE SCREW IN WITHOUT CHECKING UNDER IMAGE. THE SCREWS MISSED THE NAIL AND WERE REMOVED. EVERYTHING WAS TAKEN OUT, CLEANED AND REINSERTED. ALL SCREWS WERE ABLE TO BE INSERTED CORRECTLY THEREAFTER. THE DRILL SLEEVES AND THE LOCKING JIG WERE CHECKED AFTER THE PROCEDURE AND LINED UP CORRECTLY. CONCOMITANT DEVICES: SPIRAL BLADE (PART 462.646, LOT UNKNOWN, QUANTITY 1); GUIDE WIRE (PART

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7286216 ↗