NA 03.111.026Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982072252), received between Jul 12, 2017 and Dec 10, 2020 — 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 18, 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.

• MalfunctionDec 10, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE TIP OF THE 7MM TREPHINE ATTACHMENT BROKE OFF WHEN SURGEON WAS ATTEMPTING TO OBTAIN BONE GRAFT AT THE ILIAC CREST SITE. THE BROKEN TIP WAS REMOVED EASILY AFTER BONE HARVESTING WAS DONE. THERE WAS SURGICAL DELAY OF FIFTEEN (15) MINUTES DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) TREPHINE ATTACHMENT 7.0MM DIAMETER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10983804 ↗
• InjuryJul 30, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE IN (B)(6) 2018, THE TREPHINE ATTACHMENT 7.0 MM AND TREPHINE ATTACHMENT 5.5 MM 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 7.0 MM DIAMETER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7731055 ↗
• InjuryJul 12, 2017Break; Break

  IT WAS REPORT THAT THE PATIENT UNDERWENT ORIGINAL SURGERY ON (B)(6) 2017 WERE THE PATIENT PRESENTED WITH A LISFRANC INJURY. A RIGHT FOOT FUSION AT THE FIRST AND SECOND METATARSAL WAS PERFORMED. PATIENT WAS IMPLANTED WITH ONE (1) COMPRESSION FUSION PLATE, 4 CORTICAL SCREWS IN THE PLATE, THREE (3) INDEPENDENT CORTICAL SCREWS THAT WERE PLACED DIRECTLY INTO THE MIDFOOT BONE AND HARVESTED BONE GRAFT FROM THE PATIENT¿S MEDIAL DISTAL TIBIA BONE. DURING THE PROCEDURE, WHILE THE SURGEON WAS USING THE TREPHINE ATTACHMENT INSTRUMENT FOR BONE HARVESTING, ONE OF THE CUTTING TIPS ON THE GRAPH TUBE ATTACHMENT BROKE OFF AND BECAME EMBEDDED IN THE PATIENT¿S BONE. SURGEON CONTINUED USING THE SAME INSTRUMENT FOR BONE HARVESTING. THE REPORTED FRAGMENT IS APPROXIMATELY 2MM BY 2MM SQUARE. SURGEON WAS AWARE THE FRAGMENT WAS EMBEDDED AND CHOSE TO LEAVE IT IN PLACE. ADDITIONAL IMAGES WERE TAKEN TO IDENTIFY THE PLACEMENT OF THE FRAGMENT. ALSO, IT WAS REPORTED THAT AFTER THE PLATE, AND 2 OF THE CORTICAL SCREWS WERE IMPLANTED, THE COMPRESSION FORCEPS WERE USED. AS THE SURGEON WAS USING THE FORCEPS, IS WAS REPORTED THAT THE SPRING INSIDE THE INSTRUMENT HAD DETACHED FROM THE HANDLE. NO FRAGMENTS WERE GENERATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6707613 ↗