NA 399.19Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982202512), received between Oct 31, 2018 and Jul 21, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT THE PART OF THE TIP IS DAMAGED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559643 ↗
• MalfunctionMay 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THERE WAS A MALFUNCTION WITH THE INSTRUMENT.

  Patient problems: Insufficient Information

  MAUDE report 22028820 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A CHIP AT THE TIME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21137065 ↗
• 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 20870694 ↗
• 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 20869665 ↗
• MalfunctionApr 16, 2024Corroded; Contamination /Decontamination Problem; Material Integrity Problem; Corroded; Contamination /Decontamination Problem; Material Integrity Problem

  IT WAS FURTHER REPORTED THAT THE CUSTOMER NOTICED SOME POINTS OF CORROSION AT THE LEVEL OF THE ARTICLE AND LOT NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119134 ↗
• MalfunctionOct 2, 2023Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING LOAN KIT INSPECTION, THE TIP OF THE BONE HAMMERS IN QUESTION WERE FOUND TO BE SNAPPED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A SMALL HOHMANN RETRACTOR 8MM SHORT NARROW TIP 160MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17853707 ↗
• MalfunctionOct 17, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THESE INSTRUMENTS BROKE BUT WE USED OTHER ONE. THE SURGERY WAS DONE WITH SIMILAR ONES. IS UNKNOWN IF SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. THIS REPORT IS FOR ONE (1) SM HOHMANN RETRACT 8 SHT NARROW TIP 160 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616206 ↗
• MalfunctionOct 17, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THESE INSTRUMENTS BROKE BUT WE USED OTHER ONE. THE SURGERY WAS DONE WITH SIMILAR ONES. IS UNKNOWN IF SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/OUTCOME/CONSEQUENCES: NO. THIS REPORT IS FOR ONE (1) SM HOHMANN RETRACT 8 SHT NARROW TIP 160. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616199 ↗
• MalfunctionOct 3, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, A SMALL HOHMANN RETRACTOR WAS OBSERVED BROKEN. THERE WERE NO PATIENT NOR PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SMALL HOHMANN RETRACTOR 8MM SHORT NARROW TIP 160MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9153291 ↗
• 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 8MM SHORT NARROW TIP 160MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8026059 ↗
• 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 8MM SHORT NARROW TIP 160MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8025962 ↗