NA 399.49Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982202864), received between Apr 2, 2019 and Dec 6, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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 9 most recent of 9 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 20871264 ↗
• 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 20870688 ↗
• 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 HOHMANN RETRACTOR 15MM 160MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18633320 ↗
• 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 HOHMANN RETRACTOR 15MM 160MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17853703 ↗
• MalfunctionMar 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE FOUR (4) LOBSTER CLAW RATCHETS FROM THE INSTRUMENT TRAY DID NOT STAY SHUT. THE BABY HOMEN TIPS WERE BOTH STRAIGHT AND NOT RETRACTING PROPERLY. THIS REPORT INVOLVES ONE (1) HOHMANN RETRACTOR 15MM 160MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938139 ↗
• MalfunctionMar 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE (4) LOBSTER CLAW RATCHETS FROM THE INSTRUMENT TRAY DID NOT STAY SHUT. THE BABY HOMEN TIPS WERE BOTH STRAIGHT AND NOT RETRACTING PROPERLY. THIS REPORT INVOLVES (1) HOHMANN RETRACTOR 15MM 160MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938109 ↗
• MalfunctionMar 29, 2022Device-Device Incompatibility; Retraction Problem; Device-Device Incompatibility; Difficult to Open or Remove Packaging Material

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON FEBRUARY 28, 2022, THE FOUR (4) LOBSTER CLAW RATCHETS FROM THE INSTRUMENT TRAY DID NOT STAY SHUT. THE BABY HOMEN TIPS WERE BOTH STRAIGHT AND NOT RETRACTING PROPERLY. THIS REPORT INVOLVES ONE (1) HOHMANN RETRACTOR 15MM 160MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938067 ↗
• MalfunctionMar 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE FOUR (4) LOBSTER CLAW RATCHETS FROM THE INSTRUMENT TRAY DID NOT STAY SHUT. THE BABY HOMEN TIPS WERE BOTH STRAIGHT AND NOT RETRACTING PROPERLY. THIS REPORT INVOLVES ONE (1) HOHMANN RETRACTOR 15MM 160MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938034 ↗
• MalfunctionApr 2, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, IT WAS NOTICED THAT ONE (1) HOHMANN RETRACTOR WAS WORN OUT. IT IS UNKNOWN WHEN THE ISSUED DISCOVERED AND IF THERE WAS A PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOHMANN RETRACTOR 15MM 160MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8475723 ↗