Integra® Jarit® 121132Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780377139), received between Jul 14, 2022 and Nov 15, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2022Material Fragmentation; Material Fragmentation

  DURING AN OPEN REDUCTION INTERNAL FIXATION RIGHT DISTAL RADIUS AND SCAPHOID FRACTURE, THE NEEDLE HOLDER BROKE IN THE WOUND. ALL PIECES WERE FOUND AND VISUALIZED. TWO X-RAYS WERE TAKEN, CONFIRMING THAT THERE WAS NO FOREIGN BODY IN WOUND. NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798342 ↗
• MalfunctionAug 5, 2022Break; Break

  THE FOLLOWING INFORMATION WAS REPORTED VIA UF/IMPORTER REPORT# (B)(4), RECEIVED ON 14-JULY-2022: WHILE SURGEON WAS WORKING, NEEDLE DRIVER BROKE IN THE WOUND. ALL PIECES FOUND AND VISUALIZED. X-RAY CALLED AND 2 VIEWS TAKEN AND THERE WAS NO FOREIGN BODY IN WOUND. ORIGINAL INTENDED PROCEDURE: OPEN REDUCTION INTERNAL FIXATION RIGHT DISTAL RADIUS AND SCAPHOID FRACTURE (RIGHT) NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15175503 ↗
• MalfunctionJul 14, 2022Break

  WHILE SURGEON WAS WORKING, NEEDLE DRIVER BROKE IN THE WOUND. ALL PIECES FOUND AND VISUALIZED. X-RAY CALLED AND 2 VIEWS TAKEN AND THERE WAS NO FOREIGN BODY IN WOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15012509 ↗