NA 399.28Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982202659), received between Apr 5, 2017 and Apr 3, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Break; Break

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

  Patient problems: Insufficient Information

  MAUDE report 21763375 ↗
• MalfunctionNov 21, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE DEVICE IN QUESTION WAS FOUND SHAVED OFF. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HOHMANN RETRACTOR 24MM LONG WIDE TIP 270MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835087 ↗
• MalfunctionApr 5, 2017Break; Break

  IT WAS REPORTED THAT DURING AN ORIGINAL SURGERY FOR A HIP REPLACEMENT ON (B)(6) 2017, AS THE SURGEON WAS RETRACTING THE TISSUE AWAY FROM THE HIP BONE WITH A HOHMANN RETRACTOR, THE METAL INSTRUMENT BROKE IN HALF. NO FRAGMENTS WERE GENERATED. ANOTHER RETRACTOR WAS AVAILABLE IN THE OPERATING ROOM TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6461218 ↗