N/A 71935043Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556645949), received between Apr 17, 2018 and Aug 22, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Flaked” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A LATARJET SURGERY, IT WAS NOTICED THAT THE STRAIGHT CUT RASP RELEASED METAL SHAVINGS WHEN USING IT, THAT REMAINS INSIDE THE JOINT AND DELAYS THE SURGICAL TIME, SINCE IT WAS NECESSARY TO REMOVE THEM. THE PROCEDURE HAD BEEN COMPLETED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026905 ↗
• MalfunctionApr 11, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING SURGERY, A STRAIGHT CUT RASP RELEASED SMALL PIECES OF METAL INSIDE THE ARTICULATION. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED OR IF A DELAY OCCURRED DUE TO THIS EVENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088788 ↗
• MalfunctionOct 26, 2023Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY A STRAIGHT CUT RASP HAD EXTREME METAL ABRASION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014172 ↗
• InjuryOct 9, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC GUIDED LATARJET PROCEDURE, AFTER THE ABRASION OF THE GLENOID NECK USING THE STRAIGHT RECIPROCATING RASP, VERY THIN METALLIC PARTICLES WERE OBSERVED IN THE INTRA-ARTICULAR FLUID. NUMEROUS SMALL DEBRIS COULD NOT BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE, WITH NO SURGICAL DELAY AND NO INJURY TO PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10659388 ↗
• InjuryApr 17, 2018Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE INSTRUMENT WAS USED IN A ARTHROSCOPIC LATARJET SURGERY CASE AND THAT SMALL METAL PIECES WERE FALLING OFF THE RASP INTO THE JOINT. THE SURGEON TRIED TO GET RID OF AS MANY AS POSSIBLE BUT THERE WAS STILL SOME LEFT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7436649 ↗