NA 399.55Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982202901), received between Oct 8, 2018 and Jan 16, 2019 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2019Break; Failure to Cut; Material Twisted/Bent; Break; Failure to Cut; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE (1) CHISEL BLADE W/ 10, ONE (1) CHISEL BLADE W/ 16 AND ONE (1) PERIOSTEAL ELEVATOR 6MM CURVED BLADE - STRAIGHT EDGE WERE MARKED AS BROKEN IN MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD). THE TIP OF THE TWO (2) CHISEL BLADES WERE UNEVEN AND DULL. THE TIP OF THE PERIOSTEAL ELEVATOR WAS DINGED AND DULL. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) CHISEL BLADE 10MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8254988 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THIRTY-EIGHT (38) CHISEL BLADES WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THE THIRTY-EIGHT (38) DEVICES ARE ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) 10MM CHISEL BLADE. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8039001 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THIRTY-EIGHT (38) CHISEL BLADES WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THE THIRTY-EIGHT (38) DEVICES ARE ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) 10MM CHISEL BLADE. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8038991 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THIRTY-EIGHT (38) CHISEL BLADES WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THE THIRTY-EIGHT (38) DEVICES ARE ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) 10MM CHISEL BLADE. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8038955 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THIRTYEIGHT (38) CHISEL BLADES WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THE THIRTYEIGHT (38) DEVICES ARE ADDRESSED IN PC-(B)(4) (10), PC-(B)(4) (10), PC-(B)(4) (10), AND PC-(B)(4) (8). THIS REPORT IS FOR ONE (1) 10MM CHISEL BLADE. THIS IS REPORT 5 OF 10 FOR PC-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8038945 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THIRTY-EIGHT (38) CHISEL BLADES WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THE THIRTY-EIGHT (38) DEVICES ARE ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) 10MM CHISEL BLADE. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8038910 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THIRTYEIGHT (38) CHISEL BLADES WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THE THIRTYEIGHT (38) DEVICES ARE ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) 10MM CHISEL BLADE. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8038887 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THIRTY-EIGHT (38) CHISEL BLADES WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THE THIRTY-EIGHT (38) DEVICES ARE ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) 10MM CHISEL BLADE. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8038826 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THIRTYEIGHT (38) CHISEL BLADES WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THE THIRTYEIGHT (38) DEVICES ARE ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) 10MM CHISEL BLADE. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8038802 ↗
• MalfunctionOct 8, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CONNECTING SCREW AND CHISEL BLADE WERE TAGGED AS BROKEN AT MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD). THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) CHISEL BLADE 10MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7945057 ↗