NA 02.127.122Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982043153), received between May 2, 2019 and Sep 3, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Difficult to Maintain” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAIN HAD A BROKEN HIP PIN AFTER PATIENT'S 90-DAY CHECK UP AFTER SURGERY. PATIENT INITIALLY BROKE THEIR HIP ON (B)(6) 2024 AND WENT TO HOSPITAL WHERE PATIENT UNDERWENT THE FIRST SURGERY WITH IMPLANTS INSERTED. SOMETIME BETWEEN (B)(6) 2025, AND (B)(6) 2025, PATIENT EXPERIENCE AN INTENSE PAIN IN THEIR HIP. PATIENT WENT BACK TO ER AND X-RAY SHOWED THAT ONE OF THE PINS ON THE HIP IMPLANT WAS BROKEN. REVISION SURGERY WAS DONE ON (B)(6) 2025, TO REPLACE THE PIN. SOON AFTER THE SURGERY, THE PATIENT GOT A LOCAL INFECTION AND IS TAKING ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 22956382 ↗
• InjuryMay 2, 2019Device Difficult to Maintain; Device Difficult to Maintain

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PERCUTANEOUS DRILL BIT BROKE DURING DRILLING AND A BACK UP DEVICES WAS AVAILABLE. IT WAS NOTED THAT THE VARIABLE ANGLE LOCKING SCREW DID NOT LOCK IN THE HOLE WHERE THE DRILL BIT WAS LEFT. THERE WERE FRAGMENTS GENERATED. THE SURGEON LEFT THE HOLE EMPTY AND MOVED TO ANOTHER HOLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/22MM. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8575732 ↗