NA 399.18Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982202499), received between Aug 31, 2018 and Dec 6, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2024Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION, IT WAS DETERMINED THAT SEVERAL OF THE INSTRUMENTS WERE DULL & GAUGED DUE TO REGULAR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20872411 ↗
• MalfunctionDec 6, 2024Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION, IT WAS DETERMINED THAT SEVERAL OF THE INSTRUMENTS WERE DULL & GAUGED DUE TO REGULAR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20871410 ↗
• MalfunctionJan 15, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A BONE LEVER WAS FOUND IN MEDICAL DEVICE REPROCESSING DEPARTMENT WITH BROKEN TAG. THERE WAS A CLEAR ETCHING OR DAMAGE PRESUME TO BE FROM ANOTHER INSTRUMENT OR DRILL. THERE WERE NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) SMALL HOHMANN RETRACTOR 6MM SHORT NARROW TIP 160MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8250205 ↗
• MalfunctionOct 31, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING INSPECTION AT MEDICAL DEVICE REPROCESSING DEPARTMENT ON AN UNKNOWN DATE, THE SMALL HOHMANN RETRACTOR WITH NARROW TIP, SIZE 6MM (1 PIECE) AND 8 MM (2 PIECES) WERE NOTICED TO HAVE A BROKEN LABEL, SHEARED OFF TIPS AND DEEP SCRATCHED. THERE WAS NO PATIENT AND SURGICAL PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) SMALL HOHMANN RETRACTOR 6MM SHORT NARROW TIP 160MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8025943 ↗
• MalfunctionAug 31, 2018Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) OF THE HOHMANN RETRACTORS WERE WORN, DAMAGED AND NO LONGER FUNCTIONAL. THE PROBLEM WAS NOTICED BY THE MEDICAL DEVICE REPORTING (MDR) STAFF. IT IS UNKNOWN IF THERE WAS A PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7837918 ↗
• MalfunctionAug 31, 2018Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) OF THE HOHMANN RETRACTORS WERE WORN, DAMAGED AND NO LONGER FUNCTIONAL. THE PROBLEM WAS NOTICED BY THE MEDICAL DEVICE REPORTING (MDR) STAFF. IT IS UNKNOWN IF THERE WAS A PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7837876 ↗