NA 03.501.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587010670), received between Oct 11, 2022 and Jan 23, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2024Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 5 2024, THE PRODUCTS HAD NO EDGE. THE EVENT DIDN'T CAUSE ANY HARM TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 2.2 DB STRYKER J-LATCH/ 10 STOP/135 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18566599 ↗
• MalfunctionJan 23, 2024Failure to Cut; Failure to Cut

  THERE WAS NO SURGICAL DELAY. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18566082 ↗
• MalfunctionOct 11, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BITS STICK IN CONTACT WITH THE BONE AND BLOCK THE SYSTEM. IT NEGATIVELY AFFECTS THE PROCEDURE DUE TO INCREASED SURGICAL TIME. THERE WERE ALSO TWO DRILL BITS WITHOUT FIXED. THIS REPORT INVOLVES ONE (1) 2.2MM DRILL BIT STRYKER J-LATCH/WITH 10MM STOP/135MM. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580976 ↗
• MalfunctionOct 11, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BITS STICK IN CONTACT WITH THE BONE AND BLOCK THE SYSTEM. IT NEGATIVELY AFFECTS THE PROCEDURE DUE TO INCREASED SURGICAL TIME. THERE WERE ALSO TWO DRILL BITS WITHOUT FIXED. THIS REPORT INVOLVES ONE (1) 2.2MM DRILL BIT STRYKER J-LATCH/WITH 10MM STOP/135MM. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580964 ↗