NA 03.010.024Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982067005), received between Sep 5, 2018 and May 20, 2025 — classified as 9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT USER RECEIVED FE TRAY WITH A BROKEN HOLDING DEVICE. THIS ITEM WAS NOT USED IN SURGERY / CASE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055792 ↗
• MalfunctionSep 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, AT THE STERILE PROCESSING DEPARTMENT THE LOCKING MECHANISM ON THE HOLDING DEVICE FOR GUIDEWIRES AND REAMING RODS HAS BECOME STIFF AND DIFFICULT TO OPERATE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) HOLDING DV GUIDE WIRES & REAMING RODS. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468707 ↗
• MalfunctionSep 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE SURGEON WAS ATTEMPTING TO ADVANCE THE 2.5 MM REAMING ROD DOWN THE FEMORAL CANAL WITH THE HOLDING DEVICE FOR THE REAMING ROD. WHEN THE SURGEON FLIPPED THE SWITCH ON THE HANDLE TO LOCK ONCE THE TRIGGER WAS DEPRESSED, AN ATTEMPT WAS MADE TO ADVANCE THE REAMING ROD HOLDING DEVICE, BUT IT WOULD STILL SLIDE DOWN THE REAMING ROD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE DELAY. CONCOMITANT DEVICES: UNKNOWN HOLDING DEVICE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HOLDING DEVICE FOR GUIDE WIRES AND REAMING RODS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457293 ↗
• MalfunctionJun 30, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A STAFF MEMBER INDICATED THE HOLDING DEVICE FOR GUIDEWIRES/REAMING RODS IS BROKEN AND NO LONGER USABLE FOR SURGERY. THE SCREWS THAT CONNECT THE TRIGGER TO THE MAIN HANDLE OR ¿GUN¿ HAVE BECOME LOOSE AND FALLEN OUT. NO SURGICAL DELAY OR PATIENT ISSUES. ITEM REQUIRES REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) HAND F/GUIDE WIRE+REAMING ROD. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094781 ↗
• MalfunctionDec 31, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HINDFOOT ARTHRODESIS NAIL SET - UNDERWENT TRAY AUDIT AND PREVENTATIVE MAINTENANCE. THE INSTRUMENTS REQUIRE REPLACEMENT AS THE ENTIRE AIMING ARM SEEMS TO BE MISSING THE NAIL DURING DRILLING/SCREW INSERTION. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) HOLDING DEVICE FOR GUIDE WIRES AND REAMING RODS. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101740 ↗
• MalfunctionJan 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT WIRE INSERTER GUN WAS NOT GRIPPING THE WIRES SUFFICIENTLY DURING AN UNKNOWN CASE ON AN UNKNOWN DATE. THERE WAS NO ADVERSE EFFECT TO PATIENT AND SURGERY WAS COMPETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9632451 ↗
• MalfunctionJul 18, 2019Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF LOANER SET IT WAS OBSERVED THAT THE HOLDING DEVICE FOR GUIDE WIRES AND REAMING RODS WOULD NOT RELEASE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8804604 ↗
• MalfunctionJan 17, 2019Device-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 TIBIAL NAIL SURGERY, THE SURGEON WENT TO USE THE HANDLE FOR GUIDE WIRE BUT COULD NOT GRIP THE UNKNOWN GUIDE WIRE. ANOTHER FEMORAL NAIL SET WITH A GRIP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 10 MINUTES DELAY IN THE SURGERY DUE TO THE REPORTED EVENT. THERE WAS NO ADVERSE EVENT TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN GUIDE WIRE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) HOLDING DEVICE FOR GUIDE WIRES AND REAMING RODS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8257836 ↗
• MalfunctionSep 5, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2018, THE PATIENT UNDERWENT AN INTRAMEDULLARY NAILING OF THE FEMUR. DURING THE PROCEDURE, THE TAB ON THE STANDARD INSERTION HANDLE BROKE OFF. THE HOLDING DEVICE FOR GUIDE WIRES AND REAMING RODS WAS NOT PROPERLY GRIPPING THE REAMING ROD. THE BROKEN PIECE WAS RETRIEVED AND THE PROCEDURE CONTINUED WITH MINIMAL DELAY. THE DEVICE WAS REPLACED WITH A UNIVERSAL T HANDLE CHUCK. NO PATIENT CONSEQUENCE REPORTED. A SHORT SURGICAL DELAY OCCURRED FOR AN UNSPECIFIED AMOUNT OF TIME. IT IS UNKNOWN IF THE SURGERY WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE/S REPORTED: UNKNOWN REAMING ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7845412 ↗