RELIANCE 48360200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327268362), received between Apr 27, 2016 and Nov 12, 2018 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2018Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE DEVICE CHIPPED INTRA-OP. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8061339 ↗
• MalfunctionNov 14, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE OSTEOTOMY STRAIGHT CHISEL BOWED AT THE END AND BROKE PARTIALLY. UPDATE: PER EMAIL CORRESPONDENCE ATTACHED, "NO ADDITIONAL SURGERY, SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE WITH TWEEZERS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6099405 ↗
• MalfunctionOct 3, 2016Material Deformation; Material Integrity Problem; Break; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT: INSTRUMENT BROKE DURING THE LUMBAR ARTHRODESIS PROCEDURE. THE SURGEON USED ANOTHER INSTRUMENT THAT WAS IN THE BOX.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5994936 ↗
• MalfunctionApr 27, 2016Break; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE BREAKS AT THE SLIGHTEST IMPACT. THIS EVENT OCCURRED AFTER ONE SLAP OF THE HAMMER. THE CASE WAS COMPLETED USING AN ALTERNATIVE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5610944 ↗