NA 03.100.108Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982071064), received between Jan 15, 2019 and Mar 15, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2023Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE RETRACTOR WAS UNABLE TO STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING. IT WAS UNABLE TO USE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) ALUMINUM HOHMANN RETRACTOR 35MM WIDTH. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16548450 ↗
• MalfunctionFeb 15, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE ALUMINUM HOHMANN RETRACTOR 35MM WIDTH. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380079 ↗
• MalfunctionDec 6, 2021Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UNABLE TO STERILIZE/ASSEMBLE THE MALLEABLE RETRACTOR. CHIPPING AND CRACKING ON INSTRUMENTS. UNABLE TO USE. THIS COMPLAINT INVOLVES TEN(10) DEVICES. THIS REPORT IS FOR (1) ALUMINUM HOHMANN RETRACTOR 35MM WIDTH. THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12938819 ↗
• MalfunctionMar 17, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE ALUMINUM HOHMANN RETRACTOR TIP WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THIS REPORT IS FOR ONE (1) ALUMINUM HOHMANN RETRACTOR 35MM WIDTH. THIS IS REPORT 1 OF 1 FOR (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11508030 ↗
• MalfunctionMay 27, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RADIOLUCENT HOHMANN RETRACTOR WAS BROKEN IN THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE. THIS PC IS RELATED TO (B)(4). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10093164 ↗
• MalfunctionAug 2, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON AN UNKNOWN DATE, THE FOLLOWING WAS DISCOVERED. CHISEL BLADE - WEDGE END DAMAGED AND WORN. RETRACTOR - WEDGE END DAMAGED AND WORN. THIS REPORT IS FOR AN ALUMINUM HOHMANN RETRACTOR 35 MM WIDTH. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8854990 ↗
• MalfunctionAug 1, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON AN UNKNOWN DATE, THE RETRACTOR WEDGE END WAS DETERMINED TO BE DAMAGED AND WORN. THIS REPORT IS FOR AN ALUMINUM HOHMANN RETRACTOR 35 MM WIDTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8850310 ↗
• MalfunctionJan 15, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE RADIOLUCENT HOHMANN RETRACTOR WAS DISCOVERED TO BE MISSING. IT IS UNKNOWN IF THERE WERE PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR AN ALUMINUM HOHMANN RETRACTOR 35MM WIDTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8249979 ↗