NA 03.111.025Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982072245), received between Jul 30, 2018 and Feb 1, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2024, THAT THE INSTRUMENT BROKE DURING SURGERY. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT. THERE WAS MINIMAL INTERVENTION TO REMOVE THE RETAINED FRAGMENTS. THIS REPORT IS FOR ONE (1) TREPHINE-ATTACHM Ø5.5 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621948 ↗
• InjuryJun 1, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT TREPHINE BROKE OFF INSIDE THE PATIENT. THE SURGEON WAS REMOVING SCREWS FROM THE PATIENT, WHO ALREADY HAD HARDWARE. IN THE PROCESS, THE TREPHINE AND SCREW BROKE, LEAVING A PIECE INSIDE THE PATIENT'S FEMUR. THE PATIENT WAS NOT STABLE ENOUGH TO CONTINUE WITH THE REMOVAL. THE ISSUE WAS OBSERVED DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. THIS REPORT IS FOR ONE (1) TREPHINE ATTACHMENT 5.5MM DIAMETER THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17037541 ↗
• MalfunctionNov 10, 2022Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED ON (B)(6) 2022, THAT DURING A CORE BONE BIOPSY OF THE TIBIA, A SYNTHES TREPHINE 5.5MM ATTACHMENT 5.5MM WAS REMOVED FROM USE WHEN IT WAS APPRECIATED THAT 2 OF THE TEETH ON THE TREPHINE WERE MISSING/BROKEN. THIS REPORT IS FOR ONE (1) TREPHINE ATTACHMENT 5.5MM DIAMETER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770067 ↗
• MalfunctionJul 10, 2020Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE 5.5MM TREPHINE ATTACHMENT WAS BROKEN AND CAME OFF WHILE IT WAS USE WITH THE BONE HARVESTING INSTRUMENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN BONE HARVESTING INSTRUMENT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TREPHINE ATTACHMENT 5.5MM DIAMETER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10261440 ↗
• InjuryJul 30, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE IN (B)(6) 2018, THE TREPHINE ATTACHMENT 7.0MM AND TREPHINE ATTACHMENT 5.5MM DIAMETER BROKE OFF IN THE PATIENT DURING A PROCEDURE; MOST OF THE FRAGMENTS WERE REMOVED, BUT SOME FRAGMENTS WERE LEFT INSIDE THE PATIENT. IT IS UNKNOWN IF THERE WERE ANY SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A TREPHINE ATTACHMENT 5.5MM DIAMETER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7731091 ↗