NA 399.56Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982202925), received between Feb 9, 2017 and Jan 16, 2019 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 11 most recent of 11 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 CANADA 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 16MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8255005 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHTEEN (18) CHISEL BLADES WITH 10MM, FOURTEEN (14) CHISEL BLADES WITH 16MM AND SIX (6) CHISEL BLADES WITH 25MM WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES TOTAL THIRTY-EIGHT (38) DEVICES. THIS COMPLAINT CAPTURES EIGHT (8) DEVICES. DUE TO SYSTEM LIMITATION, THE REMAINING DEVICES ARE CAPTURED IN (B)(4). THIS REPORT IS FOR ONE (1) 16MM CHISEL BLADE. THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8039579 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHTEEN (18) CHISEL BLADES WITH 10MM, FOURTEEN (14) CHISEL BLADES WITH 16MM AND SIX (6) CHISEL BLADES WITH 25MM WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES TOTAL THIRTY-EIGHT (38) DEVICES. THIS COMPLAINT CAPTURES EIGHT (8) DEVICES. DUE TO SYSTEM LIMITATION, THE REMAINING DEVICES ARE CAPTURED IN PC-(B)(4) (10 DEVICES), PC-(B)(4) (10 DEVICES), PC-(B)(4) (10 DEVICES). THIS REPORT IS FOR ONE (1) 16MM CHISEL BLADE. THIS IS REPORT 7 OF 8 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8039566 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHTEEN (18) CHISEL BLADES WITH 10MM, FOURTEEN (14) CHISEL BLADES WITH 16MM AND SIX (6) CHISEL BLADES WITH 25MM WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES TOTAL THIRTY-EIGHT (38) DEVICES. THIS COMPLAINT CAPTURES EIGHT (8) DEVICES. DUE TO SYSTEM LIMITATION, THE REMAINING DEVICES ARE CAPTURED IN (B)(4). THIS REPORT IS FOR ONE (1) 16MM CHISEL BLADE. THIS IS REPORT 5 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8039531 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHTEEN (18) CHISEL BLADES WITH 10MM, FOURTEEN (14) CHISEL BLADES WITH 16MM AND SIX (6) CHISEL BLADES WITH 25MM WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES TOTAL THIRTY-EIGHT (38) DEVICES. THIS COMPLAINT CAPTURES EIGHT (8) DEVICES. DUE TO SYSTEM LIMITATION, THE REMAINING DEVICES ARE CAPTURED IN (B)(4). THIS REPORT IS FOR ONE (1) 16MM CHISEL BLADE. THIS IS REPORT 4 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8039494 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHTEEN (18) CHISEL BLADES WITH 10MM, FOURTEEN (14) CHISEL BLADES WITH 16MM AND SIX (6) CHISEL BLADES WITH 25MM WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES TOTAL THIRTY-EIGHT (38) DEVICES. THIS COMPLAINT CAPTURES EIGHT (8) DEVICES. DUE TO SYSTEM LIMITATION, THE REMAINING DEVICES ARE CAPTURED IN (B)(4). THIS REPORT IS FOR ONE (1) 16MM CHISEL BLADE. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8039441 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHTEEN (18) CHISEL BLADES WITH 10MM, FOURTEEN (14) CHISEL BLADES WITH 16MM AND SIX (6) CHISEL BLADES WITH 25MM WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES TOTAL THIRTY-EIGHT (38) DEVICES. THIS COMPLAINT CAPTURES EIGHT (8) DEVICES. DUE TO SYSTEM LIMITATION, THE REMAINING DEVICES ARE CAPTURED IN PC-(B)(4) (10 DEVICES), PC-(B)(4) (10 DEVICES), PC-(B)(4) (10 DEVICES). THIS REPORT IS FOR ONE (1) 16MM CHISEL BLADE. THIS IS REPORT 3 OF 8 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8039421 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, EIGHTEEN (18) CHISEL BLADES WITH 10MM, FOURTEEN (14) CHISEL BLADES WITH 16MM AND SIX (6) CHISEL BLADES WITH 25MM WERE FOUND IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD) AND TAGGED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES TOTAL THIRTY-EIGHT (38) DEVICES. THIS COMPLAINT CAPTURES EIGHT (8) DEVICES. DUE TO SYSTEM LIMITATION, THE REMAINING DEVICES ARE CAPTURED IN (B)(4). THIS REPORT IS FOR ONE (1) 16MM CHISEL BLADE. THIS IS REPORT 2 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8039366 ↗
• 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) 16MM CHISEL BLADE. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8039066 ↗
• 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) 16MM CHISEL BLADE. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8039044 ↗
• MalfunctionFeb 9, 2017Break; Break

  IT WAS REPORTED THAT DURING AN OSTEOTOMY PROCEDURE OF THE PELVIS ON (B)(6) 2017, A CHISEL BROKE. IT WAS REPORTED THAT AS THE SURGEON WAS TRYING TO COMPLETE ONE OF HIS CUTS BY USING THE CHISEL TO CUT THROUGH THE PELVIS, AS HE TWISTED THE CHISEL, IT SNAPPED. THE CHISEL BROKE AROUND THE HANDLE SO THAT THE BLADE WAS ONE LARGE PIECE. IT WAS REPORTED THAT THE BROKEN PIECE WAS EASILY RETRIEVED AND THE SURGEON COMPLETED THE PROCEDURE WITH AN OSTEOTOME. ANOTHER CHISEL WAS READILY AVAILABLE IF NEEDED BUT WAS NOT USED. THERE WAS A FIVE (5) MINUTE DELAY TO RETRIEVE THE BROKEN PART AND NO FRAGMENTS REMAINED IN THE PATIENT. THE PATIENT WAS IMPLANTED WITH THREE (3) PELVIC SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. CONCOMITANT DEVICE: MALLET (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 1), OSTEOTOME (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6318061 ↗