NA 399.48Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982202833), received between Oct 19, 2017 and Oct 21, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 THE WOODEN HANDLE IS LEECHING. THERE WAS OPERATION INVOLVED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493645 ↗
• MalfunctionDec 20, 2022Nonstandard Device; Nonstandard Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREW HANDLE ARRIVED WITHOUT A PART AND THE DRILL BITS WERE VERY WORN. THERE WAS NO REPORTED PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015430 ↗
• MalfunctionSep 1, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DEVICE WAS OPENED AND IT WAS FOUND THAT THE HANDLE OF THE DISSECTOR WAS SPLIT IN HALF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME IS OK. THIS REPORT IS FOR A PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15340343 ↗
• MalfunctionAug 22, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE IN QUESTION WAS FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INTERACTION, NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266973 ↗
• MalfunctionAug 1, 2022Break; Break

  VETERINARY COMPLAINT: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING VETERINARY TPLO PROCEDURE THE HANDLE BROKE. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 3 CRVD BLD-STR EDGE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15137867 ↗
• MalfunctionJun 3, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, DURING STERILIZATION WAS DISCOVERED THAT PERIOSTEAL ELEVATOR 3MM HANDLE WAS BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11929398 ↗
• MalfunctionNov 24, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CUSTOMER BOUGHT 2 PERIOSTEAL ELEVATORS. WHEN THEY RECEIVED THE INSTRUMENTS, BOTH INSTRUMENTS SEEMED TO HAVE BEEN SANDBLASTED ON THE HANDLE AND THE STERILIZATION DEPARTMENT REFUSED TO PROCESS THEM. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10889712 ↗
• MalfunctionNov 20, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CUSTOMER BOUGHT TWO (2) PERIOSTEAL ELEVATORS. WHEN THEY RECEIVED THE INSTRUMENTS, BOTH INSTRUMENTS SEEMED TO HAVE BEEN SANDBLASTED ON THE HANDLE AND THE STERILIZATION DEPARTMENT REFUSED TO PROCESS THEM. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10877261 ↗
• MalfunctionJun 2, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PERIOSTEAL ELEVATOR 3MM CURVED BLADE- STRAIGHT EDGE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10111627 ↗
• 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-STRAIGHT EDGE THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10088423 ↗
• MalfunctionSep 27, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PERIOSTEAL ELEVATOR 3 MM CURVED BLADE-STRAIGHT EDGE IS BROKEN. NO OTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 3 MM CURVED BLADE-STRAIGHT EDGE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131611 ↗
• MalfunctionAug 12, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, THE PERIOSTEAL ELEVATOR 3 MM CURVED BLADE-STRAIGHT EDGE WAS OBSERVED BROKEN. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8885941 ↗
• MalfunctionAug 15, 2018Break; Crack; Break; Crack

  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 - STRAIGHT EDGE. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7784457 ↗
• 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 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 (STRAIGHT EDGE) ELEVATOR. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167581 ↗
• MalfunctionOct 19, 2017Break; Break

  IT WAS REPORTED THAT THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT A PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE HAS A BROKEN HANDLE. THERE IS NO PATIENT/PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6963520 ↗