NA 323.053Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982190703), received between Mar 29, 2021 and Apr 21, 2025 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE 2025, DURING A SURGERY, FIVE PROXIMAL HUMERUS SLEEVES WERE USED. THE DRILL BIT WAS USED THROUGH FIVE SLEEVES AND SEEMED TO BEND OR WARP THE SLEEVES. THE POWER SHAFT NEEDED TO BE REMOVED THROUGH THE SLEEVE. FIVE WERE USED. THE DEPTH GAUGE WAS ALSO USED AND THE HOOK WAS SUPER BENT ON TWO OF THE DEPTH GAUGES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873294 ↗
• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE 2025, DURING A SURGERY, FIVE PROXIMAL HUMERUS SLEEVES WERE USED. THE DRILL BIT WAS USED THROUGH FIVE SLEEVES AND SEEMED TO BEND OR WARP THE SLEEVES. THE POWER SHAFT NEEDED TO BE REMOVED THROUGH THE SLEEVE. FIVE WERE USED. THE DEPTH GAUGE WAS ALSO USED AND THE HOOK WAS SUPER BENT ON TWO OF THE DEPTH GAUGES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873291 ↗
• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE 2025, DURING A SURGERY, FIVE PROXIMAL HUMERUS SLEEVES WERE USED. THE DRILL BIT WAS USED THROUGH FIVE SLEEVES AND SEEMED TO BEND OR WARP THE SLEEVES. THE POWER SHAFT NEEDED TO BE REMOVED THROUGH THE SLEEVE. FIVE WERE USED. THE DEPTH GAUGE WAS ALSO USED AND THE HOOK WAS SUPER BENT ON TWO OF THE DEPTH GAUGES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873282 ↗
• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE 2025, DURING A SURGERY, FIVE PROXIMAL HUMERUS SLEEVES WERE USED. THE DRILL BIT WAS USED THROUGH FIVE SLEEVES AND SEEMED TO BEND OR WARP THE SLEEVES. THE POWER SHAFT NEEDED TO BE REMOVED THROUGH THE SLEEVE. FIVE WERE USED. THE DEPTH GAUGE WAS ALSO USED AND THE HOOK WAS SUPER BENT ON TWO OF THE DEPTH GAUGES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873275 ↗
• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE 2025, DURING A SURGERY, FIVE PROXIMAL HUMERUS SLEEVES WERE USED. THE DRILL BIT WAS USED THROUGH FIVE SLEEVES AND SEEMED TO BEND OR WARP THE SLEEVES. THE POWER SHAFT NEEDED TO BE REMOVED THROUGH THE SLEEVE. FIVE WERE USED. THE DEPTH GAUGE WAS ALSO USED AND THE HOOK WAS SUPER BENT ON TWO OF THE DEPTH GAUGES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873270 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A CEMENTATION OF A HUMERUS, A PROXIMAL HUMERUS PLATE WAS USED. THE DRILL SLEEVES USED WERE STUCK DUE TO CEMENT ON THE DRILL BIT OR COLD WELDED ON THE SLEEVES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300744 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A CEMENTATION OF A HUMERUS, A PROXIMAL HUMERUS PLATE WAS USED. THE DRILL SLEEVES USED WERE STUCK DUE TO CEMENT ON THE DRILL BIT OR COLD WELDED ON THE SLEEVES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300708 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A CEMENTATION OF A HUMERUS, A PROXIMAL HUMERUS PLATE WAS USED. THE DRILL SLEEVES USED WERE STUCK DUE TO CEMENT ON THE DRILL BIT OR COLD WELDED ON THE SLEEVES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300577 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, DURING A CEMENTATION OF A HUMERUS, A PROXIMAL HUMERUS PLATE WAS USED. THE DRILL SLEEVES USED WERE STUCK DUE TO CEMENT ON THE DRILL BIT OR COLD WELDED ON THE SLEEVES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300486 ↗
• MalfunctionSep 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A CEMENTATION OF A HUMERUS ON AN UNKNOWN DATE IN 2024, A PROXIMAL HUMERUS PLATE WAS USED. THE DRILL SLEEVES USED WERE STUCK DUE TO CEMENT ON THE DRILL BIT OR COLD WELDED ON THE SLEEVES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 3.5MM LOCKING SCREW SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20281185 ↗
• MalfunctionOct 16, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DEVICE IN QUESTION WAS USED IN ORIF SURGERY FOR PROXIMAL HUMERUS FRACTURE. IN THE SURGERY, THE DEVICE WAS DAMAGED. THE SURGEON CONFIRMED BY X-RAY, THAT THERE WERE NO PIECES LEFT IN THE PATIENT. THIS REPORT INVOLVES ONE (1) 3.5MM LOCKING SCREW SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17939706 ↗
• MalfunctionMay 27, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE RIGHT PROXIMAL HUMERAL FRACTURE WITH THE SLEEVE IN QUESTION. WHEN THE SURGEON TRIED TO FIX THE SCREW THROUGHOUT THE GUIDING BLOCK, THE SLEEVE WAS DEFORMED. THE SURGEON USED ANOTHER SLEEVE, BUT THE SLEEVE WAS DEFORMED, TOO. THE SURGEON USED OTHER INSTRUMENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN GUIDING BLOCK (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 3.5MM LOCKING SCREW SLEEVE. THIS REPORT IS 1 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895076 ↗
• MalfunctionMar 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6), 2021, THERE WAS A LOT OF RESISTANCE WHEN INSERTING THE DRILL GUIDE. IT DID NOT FIT WELL AND AFTER INSERTION IT WAS VERY DIFFICULT TO REMOVE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585580 ↗