NA 399.36Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982202734), received between Jan 10, 2017 and Mar 18, 2026 — classified as 15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT INSTRUMENTS ARE BROKEN DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626359 ↗
• MalfunctionJan 29, 2026Break

  IT WAS REPORTED THAT A HANDLE OF THE PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE IS BROKEN. THERE WAS NO PROCEDURE AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24212043 ↗
• MalfunctionMay 14, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BROWN LIQUID CAME OUT OF THE PRODUCT DURING STERILIZATION ON APRIL 15, 2024. EVENT OCCURRED PRE-OPERATIVELY. THE HOSPITAL SUSPECTED THERE MIGHT BE PROBLEMS WITH THE RESIN MATERIAL OF THE HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS STABLE. THIS REPORT IS FOR ONE PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310717 ↗
• MalfunctionSep 26, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE HANDLE BROKE IN 2 PIECES DURING MANIPULATION. THE SURGERY WAS DELAYED FOR TWO MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1)PERIOSTEAL ELVTR 6 CRVD BLD-ROUND EDGE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17820554 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, A TRAY WAS DROPPED. AS A RESULT, AN ELEVATOR FELL AND THE HANDLE BROKE IN HALF. THERE WAS NO HOSPITAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR A PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17155408 ↗
• 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 6 CRVD BLD-ROUND EDGE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16631915 ↗
• MalfunctionJul 28, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STARDRIVE SHAFT TIP TWISTED AND TORQUED, AND IS UNABLE TO BE USED. THE HOSPITAL PROVIDED THE INSTRUMENTATION TO THE SALES REP WITHOUT ANY EXPLANATION ON EVENT OR CASE INFORMATION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR A PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15123145 ↗
• MalfunctionOct 28, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE. DURING THE PROCEDURE, THE PERIOSTEAL ELEVATOR BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10751460 ↗
• MalfunctionJun 30, 2020Break; Break

  IT WAS REPORTED THAT DURING STERILIZATION OF THE DEVICE ON (B)(6) 2020, TWO (2) 6 MM CURVED BLADE PERIOSTEAL ELEVATOR WAS OBSERVED BROKEN. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) PERIOSTEAL ELEVATOR 6 MM CURVED BLADE-ROUND EDGE THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213528 ↗
• MalfunctionJun 30, 2020Break; Break

  IT WAS REPORTED THAT DURING STERILIZATION OF THE DEVICE ON (B)(6) 2020, TWO (2) 6MM CURVED BLADE PERIOSTEAL ELEVATOR WAS OBSERVED BROKEN. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213524 ↗
• MalfunctionJan 3, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE WOODEN HANDLE ON ELEVATOR BROKE IN HALF. THERE WAS NO SURGERY DELAYED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9546171 ↗
• MalfunctionApr 19, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE OF A PERIOSTEAL ELEVATOR SLIGHTLY CURVED BLADE IS BROKEN. IT WAS DISCOVERED IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD). THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE. THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8533030 ↗
• MalfunctionDec 28, 2017Crack; Device Contamination with Chemical or Other Material; Crack; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE HANDLE ON A SYNTHES ELEVATOR IS CRACKED. THIS ISSUE WAS DISCOVERED OUTSIDE OF THE OPERATING ROOM AND THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. INVESTIGATION OF THE RETURNED DEVICE ALSO NOTED THERE WAS STAINING ON THE METAL SHAFT AND DOWEL PIN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7151348 ↗
• MalfunctionNov 6, 2017Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A CHUNK OF THE PERIOSTEAL ELEVATOR 6 MM CURVED BLADE-ROUND EDGE DEVICE WAS GOUGED OUT. THE PIECE IS MISSING WHERE THE INSTRUMENT IS ATTACHED TO THE HANDLE. THAT MISSING PIECE WAS UNABLE TO BE FOUND. THE SALES CONSULTANT IS NOT SURE WHEN IT OCCURRED. THIS HAPPENED OUTSIDE OF SURGERY. THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THE RETURNED DEVICE REVEALED A DISTAL PORTION OF THE HANDLE HAS BROKEN OFF. EVENT WAS REASSESSED BASED ON EVALUATION RESULTS AND DEEMED TO BE REPORTABLE. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 6 MM CURVED BLADE-ROUND EDGE THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7003031 ↗
• MalfunctionJan 10, 2017Break; Break

  THIS REPORT IS FOR A VETERINARY CASE. THERE WAS NO HUMAN PATIENT INVOLVEMENT. IT WAS REPORTED ON (B)(6) 2016, THAT THE HANDLE OF A PERIOSTEAL ELEVATOR CURVED BLADE SHATTERED. REPORTEDLY, ON AN UNKNOWN DATE (ABOUT ONE WEEK AGO) AFTER A CRANIAL CRUCIATE REPAIR ON A VETERINARIAN SUBJECT WAS COMPLETED, WHILE THE DOCTOR WAS COLLECTING THE INSTRUMENTS HE PICKED UP THE ELEVATOR AND PLACED IT IN A PLASTIC CONTAINER AND THE HANDLE SHATTERED. THE MALFUNCTION OCCURRED AWAY FROM THE OPERATIVE FIELD. THE FRAGMENT PIECES WERE EASILY RETRIEVED. THERE WAS NO HARM REPORTED TO THE VETERINARIAN SUBJECT. THE DOCTOR WAS UNSURE WHERE HE PURCHASED THE SYNTHES INSTRUMENT BUT REPORTED HE HAD IT SINCE APPROXIMATELY TEN (10) YEARS. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6236479 ↗