NA 03.100.109Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982071071), received between Jan 10, 2018 and Feb 19, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Material Integrity Problem

  IT WAS REPORTED THE ISSUE HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388933 ↗
• MalfunctionDec 15, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. A DAY AFTER THE SURGERY ON (B)(6) 2025, THE SALES REP WAS INFORMED THAT A NURSE DISCOVERED THAT THE TIP OF THE RETRACTOR APPEARED TO HAVE A SMALL CHIP BEFORE AND AFTER CLEANING THE INSTRUMENT. IT IS UNKNOWN WHETHER ANY REMAINED IN THE PATIENT'S BODY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809455 ↗
• MalfunctionFeb 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON DECEMBER 8, 2023, IT WAS NOTICED THAT THERE WERE SOME DENTS AND DAMAGES TO THE INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT; THIS WAS NOTED UPON INSPECTION OF THE TRAYS. NO SURGICAL CASES WERE AFFECTED. UPON INSPECTION OF THE RETURNED DEVICES, IT WAS NOTED THAT THE SDDRIVE SCREWDRIVER SHAFT T8 105MM WAS STRIPPED AND DEFORMED, THE HOHMANN RETRACTOR 15MM 160MM WAS WORN AND DEFORMED, THE ALUMINUM HOHMANN RETRACTOR 18MM WIDTH WAS BROKEN, AND THE ALUMINUM HOHMANN RETRACTOR 18MM WIDTH WAS DEFORMED AND WORN. THIS REPORT INVOLVES ONE ALUMINUM HOHMANN RETRACTOR 18MM WIDTH. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18633300 ↗
• MalfunctionFeb 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON DECEMBER 8, 2023, IT WAS NOTICED THAT THERE WERE SOME DENTS AND DAMAGES TO THE INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT; THIS WAS NOTED UPON INSPECTION OF THE TRAYS. NO SURGICAL CASES WERE AFFECTED. UPON INSPECTION OF THE RETURNED DEVICES, IT WAS NOTED THAT THE SDDRIVE SCREWDRIVER SHAFT T8 105MM WAS STRIPPED AND DEFORMED, THE HOHMANN RETRACTOR 15MM 160MM WAS WORN AND DEFORMED, THE ALUMINUM HOHMANN RETRACTOR 18MM WIDTH WAS BROKEN, AND THE ALUMINUM HOHMANN RETRACTOR 18MM WIDTH WAS DEFORMED AND WORN. THIS REPORT INVOLVES ONE ALUMINUM HOHMANN RETRACTOR 18MM WIDTH. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18633267 ↗
• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING A SURGERY THE TIP OF A RADIOLUCENT HOHMANN RETRACTOR WAS BROKE OFF. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE BROKEN TIP WAS RETRIEVED WITHOUT INCIDENT. THIS REPORT IS FOR ONE (1) ALUMINUM HOHMANN RETRACTOR 18MM WIDTH. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17033273 ↗
• MalfunctionMar 21, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS REPORT IS FOR ONE (1) RADIOLUCENT HOHMANN RETRACTOR W/18 L240.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583206 ↗
• 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 18MM WIDTH. THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12938881 ↗
• MalfunctionFeb 13, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGERY FOR PLATEAU FRACTURE WAS PERFORMED WITH RADIOLUCENT HOHMANN RETRACTOR. DURING THE SURGERY, A NURSE FOUND THE TIP OF THE RETRACTOR HAD BROKEN. THE SURGEON THOUGHT THAT IT BROKE DURING DRILLING. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - DRILL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1). THIS REPORT IS FOR ONE (1) ALUMINUM HOHMANN RETRACTOR 18MM WIDTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9706543 ↗
• MalfunctionJan 10, 2018Break; Material Fragmentation; Break; Material Fragmentation

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE ALUMINUM HOHMANN RETRACTOR WAS USED DURING A PROCEDURE TO REPAIR A FEMORAL TROCHANTERIC FRACTURE ON (B)(6) 2017. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE PROCEDURE THE STAFF WAS WASHING AND INSPECTING THE DEVICE AND NOTICED THAT THE TIP OF THE RETRACTOR WAS BROKEN. IT IS NOT KNOWN IF THE DEVICE BROKE INTRAOPERATIVELY OR POSTOPERATIVELY. NO CONFIRMATION WAS MADE TO DETERMINE IF THE BROKEN TIP REMAINS IN THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7178379 ↗