NA 314.11Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982188519), received between Jun 4, 2019 and Feb 5, 2026 — classified as 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT INTERNAL METAL BALL BEARING OF HOLDING SLEEVE WAS MISSING, RENDERING THE INSTRUMENT NONFUNCTIONAL FOR HOLDING SCREWS. THIS ITEM WAS SUBSEQUENTLY DISCARDED. THERE WAS NO PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270194 ↗
• MalfunctionFeb 4, 2026Device-Device Incompatibility; Noise, Audible

  IT WAS REPORTED THAT THE COMPONENTS OF THE DEVICE ARE GRINDING AND THE INSTRUMENT BEING UNABLE TO DISASSEMBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24262199 ↗
• MalfunctionOct 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN POST-OP DATE IN 2023 THE HOLDING SLEEVES WOULD NOT OPEN UP TO CAPTURE THE SCREW. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18022874 ↗
• MalfunctionOct 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN POST-OP DATE IN 2023 THE HOLDING SLEEVES WOULD NOT OPEN UP TO CAPTURE THE SCREW. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18022732 ↗
• MalfunctionAug 3, 2023Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE INSTRUMENT BROKE AT THE TOP OF IT X 2 MISSING SPRING FOR HOLDING SLEEVE. THERE WAS NO SURGICAL DELAY DUE TO THE RELATED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE. THIS IS REPORT 2 OF 4 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451764 ↗
• MalfunctionJan 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, DURING AN ATTEMPT TO USE HOLDING SLEEVE TO PICK UP 4.5MM CORTEX SCREW, THE HOLDING SLEEVE WAS JAMMING AND WAS STICKY SO COULD NOT BE USED. THE SCREW WAS PICKED UP AND PASSED OVER WITHOUT USING SLEEVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13193908 ↗
• MalfunctionOct 8, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, THE HOLDING SLEEVE WAS OBSERVED TO HAVE A MISSING PIECE. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9168104 ↗
• MalfunctionJun 4, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF LOANER SET AT A FIELD STOCK LOCATION SITE, IT WAS OBSERVED THAT THE HOLDING SLEEVE WAS MISSING A COMPONENT. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8667966 ↗