NA 399.40Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982202789), received between Apr 13, 2018 and Jul 9, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE HANDLES ARE LEAVING A BROWN STAIN IN POUCHES AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460897 ↗
• MalfunctionMay 21, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 29, 2024 DURING STERILIZATION, THE HANDLE MATERIAL OF THE PERIOSTEAL ELEVATOR IN QUESTION WAS LEAKING/STAINING. THE EVENT OCCURRED OUTSIDE OF SURGERY. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 6 CRVD BLD-STR EDGE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19362299 ↗
• MalfunctionMar 20, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 DURING STERILIZATION, THE HANDLE MATERIAL OF THE PERIOSTEAL ELEVATOR IN QUESTION WAS LEAKING/STAINING. THE EVENT OCCURRED OUTSIDE OF SURGERY, THERE WAS NO PATIENT OR PROCEDURE IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18939501 ↗
• MalfunctionDec 5, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE HANDLE OF ITEM PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE HAD BROKEN AND NEEDED TO BE REPLACED. THERE WERE NO PATIENT CONSEQUENCES AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916719 ↗
• MalfunctionNov 1, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2022, DURING THE SURGERY, THE DOCTOR REQUESTED A THIN DISSECTOR, WHICH WAS PROVIDED IN THE EQUIPMENT. WHEN STARTING TO USE IT, THE HANDLE SPLIT INTO TWO, ANOTHER SYSTEM WAS USED, SINCE IT CAME WITH SEVERAL. THE PROCEDURE WAS NOT DELAYED. WHEN FINISHED, THE PIECE WAS REASSEMBLED, MASKING TAPE IS APPLIED AND LEFT IN THE EQUIPMENT AGAIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708765 ↗
• MalfunctionMar 19, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2020, THE SHAFT BROKE IN TWO PARTS. THE DISTAL PART WAS DISCARDED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9853886 ↗
• MalfunctionJan 16, 2019Break; Material Twisted/Bent; Break; 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) PERIOSTEAL ELEVATOR 6MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8255021 ↗
• MalfunctionJan 15, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PERIOSTEAL ELEVATOR CURVED BLADE STRAIGHT EDGE IS COMING APART FOUND BY STERILE PROCESSING STAFF. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT.  THIS COMPLAINT INVOLVES ONE (1) DEVICE.  THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8249098 ↗
• MalfunctionApr 13, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING STERILE PROCESSING, THE BROWN HANDLES OF TWO (2) PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGES BLED INTO THE TRAY. THIS DID NOT OCCUR DURING SURGERY AND THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) PARTS. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7430198 ↗