Erisma®-LP 13911009Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700780627271), received between Sep 26, 2019 and Sep 13, 2023 — classified as 5 malfunctions.

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

• MalfunctionSep 13, 2023Fracture; Fracture

  DRIVERS DISTAL END IS SHEARED OFF. IT IS UNKNOWN IF THIS OCCURRED PRIOR TO OR DURING SURGERY. THE TIP WAS NOT FOUND IN THE SURGICAL SITE OR ON X-RAYS. THERE WAS NO HARM TO THE PATIENT AND NO DELAY TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17739279 ↗
• MalfunctionMar 10, 2021Material Fragmentation; Material Fragmentation

  AFTER STERILIZATION HAD BEEN COMPLETED AND THE INSTRUMENTS WERE BEING PUT BACK INTO THE TRAYS IT WAS NOTICED THAT THE TIP OF THE SCREWDRIVER HAD BROKEN OFF. THE TIP WAS NOT LOCATED, AND IT IS UNSURE WHEN THE BREAKAGE OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 11453367 ↗
• MalfunctionDec 30, 2019Material Fragmentation; Material Fragmentation

  MIS SCREWDRIVER TIP BROKE INTRAOPERATIVELY. THE SCREWDRIVER BECAME DISENGAGED FROM THE SCREW DURING INSERTION. UPON REMOVING THE SCREW DRIVER FROM THE PATIENT, THE TECH NOTICED THAT THE TIP OF THE SCREWDRIVER WAS BROKEN. IT WAS NOT SEEN ON XRAYS OF THE PATIENT OR FOUND IN THE SURGICAL FIELD. A SECOND SCREWDRIVER WAS USED IN ITS PLACE AND THE SURGERY COMPLETED WITHOUT ANY FURTHER COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9532954 ↗
• MalfunctionOct 1, 2019Material Fragmentation; Material Fragmentation

  UPON RECEIPT INSPECTION OF A SET AFTER A TRANSFER, THE INITIAL REPORTER NOTICED THE TIP WAS BROKEN FROM AN MIS SCREWDRIVER SHAFT IN THE SET. THE TIP WAS NOT LOCATED IN THE SET. THE INSTRUMENT WAS NOT USED IN ANY SURGERIES BY THE INITIAL REPORTER.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 9142501 ↗
• MalfunctionSep 26, 2019Material Fragmentation; Material Fragmentation

  THE TIP OF THE ERISMA-LPMIS SCREWDRIVER SHAFT WAS NOTICED TO BE BROKEN AFTER RECEIPT FROM STERILE PROCESSING. IT IS UNKNOWN IF THE BREAKAGE HAPPENED DURING SURGERY OR ELSEWHERE.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 9125234 ↗