NA 387.660Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982197702), received between Oct 12, 2018 and Apr 14, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES, REPORTS AN EVENT IN SINGAPORE AS FOLLOWS: IT WAS REPORTED, ON UNKNOWN DATE, THAT TREPHINE ATTACHMENT TIP BROKE IN PATIENT BONE WHILE HARVESTING BONE GRAFT. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT'S OUTCOME IS, NO ONE NOTICED THAT THE TIP OF THE TREPHINE ATTACHMENT WAS BROKEN DURING THE HARVESTING INTRAOPERATIVELY. THEY NOTICED IT ONLY DURING INSTRUMENT WASHING. THEY DID AN X-RAY AND FOUND A "FRAGMENT" UNDER THE I/I. THE SURGEON DECIDED NOT TO BRING THE PATIENT IN FOR ANOTHER OPERATION TO RETRIEVE THE FRAGMENT. NO INTERVENTION IS NEEDED AT THE MOMENT. THIS REPORT IS FOR ONE (1) TREPHINE-ATTACHM Ø9.5 F/HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16743155 ↗
• MalfunctionNov 4, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THERE ARE TWO (2) BONE HARVESTER FOUND THAT HAD BROKEN TEETH. FOUND THEM AFTER BEING WASHED TO STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) TREPHINE ATTACHMENT 9.5MM DIAMETER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752854 ↗
• InjuryOct 12, 2018Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018. AFTER THE SURGERY, TWO (2) TREPHINE ATTACHMENTS WERE FOUND TO HAVE A MISSING TOOTH. THE SURGEON WAS INFORMED, AND AN X-RAY WAS DONE. IT WAS DISCOVERED THAT ONE PIECE WAS RETAINED IN THE PATIENT. THE SURGEON DECIDED TO LEAVE THE PIECE IN THE PATIENT. PATIENT CONSEQUENCE IS UNKNOWN. THIS REPORT IS FOR A TREPHINE ATTACHMENT 9.5MM DIAMETER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7962217 ↗