NA 399.481Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982202857), received between Aug 30, 2017 and Apr 23, 2024 — classified as 8 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED THAT ON 4/02/3034 THE GRITTY PART BETWEEN PLIERS HAS WORN OFF AND THE OTHER ONE HAS A LOOSE HANDLE, ALSO, ONE OF THE PERIOSTEAL ELVTR 3 CRVD BLD - ROUND EDGE END IS CHIPPED AND ONE END ON THE OTHER IS DULL . THERE WAS NO OPERATION / PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELVTR 3 CRVD BLD - ROUND EDGE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19168618 ↗
• MalfunctionMar 28, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE HANDLES OF THE ELAVATORS LEAVE STAINS ON THE PEEL PACKS AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELVTR 3 CRVD BLD - ROUND EDGE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16631904 ↗
• MalfunctionApr 21, 2022Break; Crack; Break; Crack

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A PHENOLIC HANDLE IS CRACKED AND THUS CAN NOT BE CLEANED PROPERLY. THIS WAS DISCOVERED PRE-OPERATIVELY ON AN UNKNOWN DATE WITH NO KNOWN PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A PERIOSTEAL ELEVATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14167956 ↗
• MalfunctionMay 26, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION, A BENDING PLIERS WOULD NOT OPEN DUE TO RUST EMBEDDED IN THE GROOVES AND SPRING. THE THREADS OF AN EXTRACTION SCREW WERE STRIPPING, A STARDRIVE SCREWDRIVER SHAFT TIP IS WARPING DUE TO WEAR, 2 PERIOSTEAL ELEVATOR (ROUND AND STRAIGHT) HAVE STAINING BETWEEN THE WOODEN HANDLE AND ELEVATOR, A GRAPHIC CASE TOP COAT OF AUX BIN IS STARTING TO PEEL, AND THE DEPTH GAUGE HANDLE HAS A CRACK THROUGH IT. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR 1 PERIOSTEAL ELEVATOR 3MM CURVED BLADE-ROUND EDGE THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10088421 ↗
• MalfunctionFeb 4, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 15, 2019, A PERIOSTEAL ELEVATOR ROUND EDGE-CURVED BLADE AND A SMALL HEXAGONAL SCREWDRIVER WERE DISCOVERED TO HAVE CRACKED HANDLES AND STAINED POUCHES. THIS WAS DISCOVERED DURING STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8302427 ↗
• MalfunctionAug 15, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE CENTRAL PROCESSING MANAGER PRESENTED ONE (1) PERIOSTEAL ELEVATOR CURVED BLADE-ROUND EDGE, ONE (1) PERIOSTEAL ELEVATOR CURVED BLADE-STRAIGHT EDGE, ONE (1) CRUCIFORM SCREWDRIVER, AND ONE (1) REDUCTION FORCEPS WITH POINTS RATCHET THAT WERE CRACKED OR BROKEN. IT WAS UNKNOWN WHEN THE DEVICES BECAME DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7784452 ↗
• MalfunctionJan 5, 2018Material Discolored; Material Discolored

  IT WAS REPORTED THAT SEVERAL INSTRUMENTS AT THE FACILITY ARE DISCOLORED. THE CANNULATED 4.0MM HEXAGONAL SCREWDRIVER, THE PERIOSTEAL ELEVATOR 3MM CURVED BLADE (STRAIGHT EDGE), THE PERIOSTEAL ELEVATOR 3MM CURVED BLADE (ROUND EDGE), AND THE HOLDING SLEEVE. WHEN PEEL PACKED, THE HANDLES ARE LEACHING A BROWN SUBSTANCE ON THE BACKING OF THE PEEL PACK. THE HANDLES HAVE A DULL, ROUGH FINISH. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR A CURVED BLADE (ROUND EDGE) ELEVATOR. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167677 ↗
• MalfunctionAug 30, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SCREW DRIVER WOODEN HANDLES FROM A MODULAR HAND SYSTEM ARE BLEEDING AND LEAVING STAINS ON THE LIDS AND CAUSING A CONCERN. THERE IS NO PATIENT INVOLVED AS THIS IS HAPPENING IN STERILE PROCESSING DEPARTMENT. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6832122 ↗