Integra® Jarit® 121135Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780377160), received between Sep 20, 2019 and Jan 5, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 5, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INSTRUMENT WAS BEING USED ON THE FIELD IN THE PATIENT'S RIGHT LEG DURING INSERTION OF AN INTRAMEDULLARY NAIL (FEMUR). A PIECE OF THE TIP WAS FOUND IN THE LEG WHILE USING C-ARM DURING PROCEDURE. THE PIECE WAS REMOVED FROM THE PATIENT AND PLACED IN A SPECIMEN CUP WITH LID. THE INSTRUMENT AND SPECIMEN CUP WERE IMMEDIATELY REMOVED FROM THE STERILE FIELD AND GIVEN TO CIRCULATOR. AN X-RAY WAS TAKEN TO CONFIRM THAT NO RETAINED OBJECTS REMAINED. THERE WAS NO CONSEQUENCE TO PATIENT AS A RESULT OF THE PRODUCT PROBLEM AND NO PROCEDURAL DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16110153 ↗
• MalfunctionOct 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION RECEIVED VIA MEDWATCH UF/IMPORTER REPORT# (B)(4): "INSTRUMENT WAS BEING USED ON THE FIELD IN PATIENT'S RIGHT LEG. PIECE OF TIP WAS FOUND IN LEG WHILE USING C-ARM DURING PROCEDURE. PIECE REMOVED FROM PATIENT AND PLACED IN SPECIMEN CUP WITH LID. INSTRUMENT AND SPECIMEN CUP IMMEDIATELY REMOVED FROM STERILE FIELD AND GIVEN TO CIRCULATOR. X-RAY TO CONFIRM NO RETAINED OBJECTS OBTAINED." ORIGINAL INTENDED PROCEDURE: INSERTION INTRAMEDULLARY NAIL FEMUR. IT WAS SUBSEQUENTLY REPORTED THAT THERE WAS NO CONSEQUENCE TO PATIENT AS A RESULT TO PRODUCT PROBLEM AND NO PROCEDURAL DELAY OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 15611971 ↗
• InjurySep 20, 2019Fracture; Fracture

  WHILE USING THE 121135 CARB-BITE MAYO-HEGAR NEEDLE HOLDER 6 ON A PATIENT DURING AN UNSPECIFIED PROCEDURE, THE DEVICE FAILED TO HOLD SUTURE. THE SURGEON TRIED USING A SECOND 121135 CARB-BITE MAYO-HEGAR NEEDLE HOLDER 6, BUT IT ALSO FAILED TO HOLD SUTURE. POSTOPERATIVELY, AFTER THE CLOSURE OF THE PATIENT, AN X-RAY WAS TAKEN. A FOREIGN BODY WAS SEEN ON THE FILM. THE SCRUB TECHNICIAN WENT BACK TO THE TRAY AND NOTICED THAT THE DEVICE HAD A BROKEN TIP. THE PATIENT WAS LATER BROUGHT BACK INTO SURGERY AND HAD THE NEEDLE HOLDER TIP REMOVED. THERE WAS AN UNSPECIFIED INJURY AND DELAY IN SURGERY REPORTED. (EVENT REPORT FOR DEVICE #1 OF 2).

  Patient problems: Foreign Body In Patient

  MAUDE report 9098906 ↗
• InjurySep 20, 2019Fracture; Fracture

  WHILE USING THE 121135 CARB-BITE MAYO-HEGAR NEEDLE HOLDER 6 ON A PATIENT DURING AN UNSPECIFIED PROCEDURE, THE DEVICE FAILED TO HOLD SUTURE. THE SURGEON TRIED USING A SECOND 121135 CARB-BITE MAYO-HEGAR NEEDLE HOLDER 6, BUT IT ALSO FAILED TO HOLD SUTURE. POSTOPERATIVELY, AFTER THE CLOSURE OF THE PATIENT, AN X-RAY WAS TAKEN. A FOREIGN BODY WAS SEEN ON THE FILM. THE SCRUB TECHNICIAN WENT BACK TO THE TRAY AND NOTICED THAT THE DEVICE HAD A BROKEN TIP. THE PATIENT WAS LATER BROUGHT BACK INTO SURGERY AND HAD THE NEEDLE HOLDER TIP REMOVED. THERE WAS AN UNSPECIFIED INJURY AND DELAY IN SURGERY REPORTED. (EVENT REPORT FOR DEVICE #2 OF 2)

  Patient problems: Foreign Body In Patient

  MAUDE report 9098171 ↗