NA 03.120.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982074287), received between Feb 14, 2018 and Aug 25, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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.

• MalfunctionAug 25, 2021Device-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, THE SURGEON SET THE PLATE FOR THE GUIDING BLOCK AT THE DEMONSTRATION. AFTER THE DEMONSTRATION, BY USING THE DRILL SLEEVE TO REMOVE THE PLATE FROM THE GUIDING BLOCK, BUT THE PLATE COULDN'T BE REMOVED FROM THE GUIDING BLOCK. FINALLY, REMOVE THE GUIDING BLOCK ABOUT 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES (3) DEVICES. THIS REPORT IS FOR (1) DRILL SLEEVE FOR 2.8MM DRILL BIT. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367161 ↗
• MalfunctionJul 19, 2021Device-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, THE GUIDING BLOCK AND THE LOCKING ATTACHMENT PLATE GOT STUCK AND WERE NOT COME OFF DURING ASSEMBLY FOR DEMONSTRATION. ALSO, THE GUIDING BLOCK CAME OFF EVENTUALLY. AS WELL AS THE CONNECTING SCREW ALSO CAME OFF AT THE SAME TIME. THE TIP OF THE SCREWDRIVER WHICH WAS USED TO LOCK THE UPPER PART OF THE CONNECTING SCREW HAD BEEN CHIPPED OFF. THE SCREWDRIVER WAS UNABLE TO GRASP THE UPPER PART OF THE CONNECTING SCREW. THESE DEVICES AND IMPLANTS WERE PREPARED FOR DEMONSTRATION IN STUDY MEETING. THESE EVENTS DON'T INCLUDE ANY PATIENTS. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES (6) DEVICES. THIS REPORT IS FOR (1) DRILL SLEEVE FOR 2.8MM DRILL BIT. THIS REPORT IS 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12193538 ↗
• MalfunctionJul 19, 2021Device-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, THE GUIDING BLOCK AND THE LOCKING ATTACHMENT PLATE GOT STUCK AND WERE NOT COME OFF DURING ASSEMBLY FOR DEMONSTRATION. ALSO, THE GUIDING BLOCK CAME OFF EVENTUALLY. AS WELL AS THE CONNECTING SCREW ALSO CAME OFF AT THE SAME TIME. THE TIP OF THE SCREWDRIVER WHICH WAS USED TO LOCK THE UPPER PART OF THE CONNECTING SCREW HAD BEEN CHIPPED OFF. THE SCREWDRIVER WAS UNABLE TO GRASP THE UPPER PART OF THE CONNECTING SCREW. THESE DEVICES AND IMPLANTS WERE PREPARED FOR DEMONSTRATION IN STUDY MEETING. THESE EVENTS DON'T INCLUDE ANY PATIENTS. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1). DRILL SLEEVE FOR 2.8MM DRILL BIT. THIS REPORT IS 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12193513 ↗
• MalfunctionFeb 14, 2018Failure to Align; Failure to Align

  (B)(6) REPORTED FOLLOWING: IT WAS DISCOVERED DURING AN UNKNOWN FEMUR TREATMENT SURGERY ON AN UNKNOWN DATE THAT THE DISTAL THREADS OF A DRILL SLEEVE WERE DAMAGED. THERE WAS NO REPORTED SURGICAL DELAY AND THE SURGERY COULD BE COMPLETED USING ANOTHER AVAILABLE DRILL SLEEVE. THE PATIENT WAS REPORTED TO BE IN GOOD STANDING FOLLOWING THE PROCEDURE. CONCOMITANT DEVICES REPORTED: DRILL BIT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DRILL SLEEVE FOR 2.8MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7269886 ↗