NA 387.662Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982197726), received between Jun 25, 2018 and Mar 20, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 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.

• InjuryMar 20, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN EXTRACTION OF AN ILIAC CREST BONE GRAFT OF THE LEFT SIDE, THAT THE TOOTH OF THE TREPHINE ATTACHMENT 12.5 MM BROKE OFF DURING THE DRILLING/ MILLING STEP. THE FRAGMENT REMAINED IN THE BONE OF THE PATIENT. CONCOMITANT DEVICE REPORTED: UNK - BONE GRAFT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN GUIDE WIRE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE TREPHINE ATTACHMENT 12.5MM DIAMETER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 9861388 ↗
• MalfunctionJun 25, 2018Break; Material Fragmentation; Break; Material Fragmentation

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2018, THE TREPHINE BROKE OFF AND ONE OF THE TIPS CREATED SHARDS WHEN DOING DO. X RAY WAS USED TO DETERMINE NOTHING WAS LEFT IN THE PATIENT AND SURGEON WAS SATISFIED. THE BONE HARVESTING HAD BEEN ACHIEVED SO IT WAS ONLY THE PROCESS OF REMOVING THE SHARDS THAT CAUSED THE DELAY. THIS REPORT IS FOR ONE (1) TREPHINE ATTACHMENT 12.5MM DIAMETER (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7634023 ↗