NA 03.010.081Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982067517), received between Apr 25, 2022 and Jan 6, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  THE SLEEVE HAD A SMALL DAMAGE AT THE TIP, AND COULD NOT BE INSERTED INTO THE AIMING ARM ATTACHMENT/COULD ONLY BE INSERTED WITH FORCE. NO PATIENT IMPACT OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079435 ↗
• MalfunctionDec 28, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 05-DECEMBER-2023, THE POSITIVE-DRILL STOP FEATURE ON THE SHAFT IN QUESTION WAS FOUND TO BE WORN. BECAUSE OF THIS WEAR, THE SLEEVE NO LONGER STOPS DRILL BITS FROM ENTERING IN TOO FAR. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 15.0MM/13.0MM PROTECTION SLEEVE F/SPIRAL BLD AIMING ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18412147 ↗
• MalfunctionNov 24, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE SURGEON REPORTED THAT THE DRILL BIT WAS BINDING INSIDE THE PROTECTION SLEEVE WHILE PREPARING FOR A SPIRAL BLADE WHILE USING THE RETROGRADE/ANTEGRADE FEMORAL NAIL INSTRUMENTS. THE POSITIVE STOP FEATURE BETWEEN THE SLEEVE AND DRILL BIT WAS WORN, CAUSING THE DRILL BIT TO PASS TOO DEEP INTO THE SLEEVE AND CAUSING THE BIT TO BIND WITHIN THE SLEEVE. AS A RESULT OF THE BINDING, THE DRILL BIT AND SLEEVE BECAME HOT, RESULTING IN A MINOR THERMAL INJURY TO THE PATIENT¿S SKIN. THE INSTRUMENTS WERE REMOVED FROM THE SET AND DISCARDED. THE INSTRUMENTS REQUIRE REPLACEMENT. THERE WERE PATIENT OUTCOMES AND CONSEQUENCES. THERE WAS A THERMAL INJURY TO THE PATIENT'S SKIN. THIS REPORT IS FOR ONE (1) PROTECT SLEEVE 15/13 F/SPIR BLADE LOCK Y. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Burn(s)

  MAUDE report 18204388 ↗
• MalfunctionNov 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT UPON INSPECTION FOLLOWING A PROCEDURE ON (B)(6) 2023, STAFF NOTED THAT A DRILL BIT WAS BINDING INSIDE A PROTECTION SLEEVE. PROCEDURE HAD BEEN COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 15.0MM/13.0MM PROTECTION SLEEVE F/SPIRAL BLD AIMING ARM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187161 ↗
• MalfunctionSep 2, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE 13.0MM CANNULATED DRILL BIT ¿SHOULDERS¿ COULD PASS THE AUTOMATIC STOP POSITION AND ENTER INTO THE 15.0MM/13.0MM PROTECTION SLEEVE. THE REAMER WOULD GO THROUGH THE SLEEVE ANOTHER 10MM OR SO. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY SECOND DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 15.0MM/13.0MM PROTECTION SLEEVE F/SPIRAL BLD AIMING ARM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348311 ↗
• MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A 15/13 F/SPIRAL BLADE-LOCK PROTECT SLEEVE AND A 13.0MM/3.2MM WIRE GUIDE FOR SPIRAL BLADE AIMING ARM WERE DAMAGED UPON INSPECTION OF INSTRUMENTS PRIOR TO SURGERY. THE SLEEVE WAS STATED TO NOT FIT THROUGH THE JIG EASILY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) DRILLSL 13/3.2 F/03.010.081 YELL. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192968 ↗