NA 324.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982190949), received between Oct 9, 2018 and Jul 29, 2022 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON, PRE-OPERATIVELY TO THE SURGERY, TESTED THE INSTRUMENTATION. IT WAS NOTED THAT THE CANNULAS DID NOT FIT THE AIMING ARM THERE WAS NO PATIENT OUTCOMES/CONSEQUENCES REPORTED. THIS IS REPORT 6 OF 7 FOR (B)(4). THIS REPORT IS FOR AN INSERTION SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15131441 ↗
• MalfunctionJul 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON, PRE-OPERATIVELY TO THE SURGERY, TESTED THE INSTRUMENTATION. IT WAS NOTED THAT THE CANNULAS DID NOT FIT THE AIMING ARM THERE WAS NO PATIENT OUTCOMES/CONSEQUENCES REPORTED. THIS IS REPORT 4 OF 7 FOR (B)(4). THIS REPORT IS FOR AN INSERTION SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15131393 ↗
• MalfunctionJul 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON, PRE-OPERATIVELY TO THE SURGERY, TESTED THE INSTRUMENTATION. IT WAS NOTED THAT THE CANNULAS DID NOT FIT THE AIMING ARM THERE WAS NO PATIENT OUTCOMES/CONSEQUENCES REPORTED. THIS IS REPORT 5 OF 7 FOR (B)(4). THIS REPORT IS FOR AN INSERTION SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15131384 ↗
• MalfunctionJul 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON, PRE-OPERATIVELY TO THE SURGERY, TESTED THE INSTRUMENTATION. IT WAS NOTED THAT THE CANNULAS DID NOT FIT THE AIMING ARM THERE WAS NO PATIENT OUTCOMES/CONSEQUENCES REPORTED. THIS IS REPORT 2 OF 7 FOR (B)(4). THIS REPORT IS FOR AN INSERTION SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15131382 ↗
• MalfunctionJul 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON, PRE-OPERATIVELY TO THE SURGERY, TESTED THE INSTRUMENTATION. IT WAS NOTED THAT THE CANNULAS DID NOT FIT THE AIMING ARM THERE WAS NO PATIENT OUTCOMES/CONSEQUENCES REPORTED. THIS IS REPORT 3 OF 7 FOR (B)(4). THIS REPORT IS FOR AN INSERTION SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15131342 ↗
• MalfunctionJul 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON, PRE-OPERATIVELY TO THE SURGERY, TESTED THE INSTRUMENTATION. IT WAS NOTED THAT THE CANNULAS DID NOT FIT THE AIMING ARM THERE WAS NO PATIENT OUTCOMES/CONSEQUENCES REPORTED. THIS IS REPORT 1 OF 7 FOR (B)(4). THIS REPORT IS FOR AN INSERTION SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15131314 ↗
• MalfunctionJul 28, 2022Break; Break

  IT WAS REPORTED THE DEPTH GAUGE WAS BROKEN. NO PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR A INSERTION SLEEVE. THIS IS REPORT 4 OF 5 FOR (B)(4). THIS COMPLAINT IS RELATED TO ANOTHER COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120649 ↗
• MalfunctionJan 31, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE METAL RING ON THE DRILL SLEEVE FOR LISS INSERTION GUIDE FELL OFF DURING SURGERY. THE BROKEN PIECE WAS FOUND BY STAFF. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE (1) INSERTION SLEEVE FOR 5.0MM TI LOCKING SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13391910 ↗
• MalfunctionAug 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION SLEEVES ARE FAILING TO SEAT INTO HOLES IN THE AIMING ARM AND THE POWER DRIVER SHAFT IS GETTING STUCK INSIDE THE TUBE DURING INSERTION AND WHEN REMOVING THE POWER DRIVER. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK: GUIDES/SLEEVES/AIMING: AIMING ARM (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES (6) DEVICES. THIS REPORT IS FOR (1) INSERTION SLEEVE FOR 5.0 TI LCKNG SCREWS. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259348 ↗
• MalfunctionAug 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION SLEEVES ARE FAILING TO SEAT INTO HOLES IN THE AIMING ARM AND THE POWER DRIVER SHAFT IS GETTING STUCK INSIDE THE TUBE DURING INSERTION AND WHEN REMOVING THE POWER DRIVER. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) INSERTION SLEEVE FOR 5.0 TI LCKNG SCREWS. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259065 ↗
• MalfunctionAug 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION SLEEVES ARE FAILING TO SEAT INTO HOLES IN THE AIMING ARM AND THE POWER DRIVER SHAFT IS GETTING STUCK INSIDE THE TUBE DURING INSERTION AND WHEN REMOVING THE POWER DRIVER. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) INSERTION SLEEVE FOR 5.0 TI LCKNG SCREWS. . THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259063 ↗
• MalfunctionAug 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION SLEEVES ARE FAILING TO SEAT INTO HOLES IN THE AIMING ARM AND THE POWER DRIVER SHAFT IS GETTING STUCK INSIDE THE TUBE DURING INSERTION AND WHEN REMOVING THE POWER DRIVER. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) INSERTION SLEEVE FOR 5.0 TI LCKNG SCREWS. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259055 ↗
• MalfunctionOct 9, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING INSPECTION ON (B)(6) 2018, TWO DEVICES WERE HAVING A PROBLEM. THE INSERTION SLEEVE THAT IS SUPPOSED TO HOLD THE DRILL GUIDE OR WIRED GUIDE, GETS STUCK WHEN IT IS INSERTED. ON ANOTHER INSERTION SLEEVE, THE WIRED RING THAT GOES AROUND THE AIMING ARM WAS BENT UP AND WILL NOT FIT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) INSERTION SLEEVE FOR 5.0MM TI LOCKING SCREWS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7946881 ↗
• MalfunctionOct 9, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING INSPECTION ON (B)(6) 2018, TWO DEVICES WERE HAVING A PROBLEM. THE INSERTION SLEEVE THAT IS SUPPOSED TO HOLD THE DRILL GUIDE OR WIRED GUIDE, GETS STUCK WHEN IT IS INSERTED. ON ANOTHER INSERTION SLEEVE, THE WIRED RING THAT GOES AROUND THE AIMING ARM WAS BENT UP AND WILL NOT FIT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) INSERTION SLEEVE FOR 5.0MM TI LOCKING SCREWS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7946786 ↗