inforMED
MalfunctionFHQ

INTEGRA JARIT

Received Jul 9, 2026 · Event occurred Jun 2, 2026

Report 25762383 · MDR key 25762383

Device

Generic name

Holder, Needle, Gastroenterologic

Model number

120210

Catalog number

120-210

Patient

79 YR · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

FROM STAFF: TOWARDS THE END OF A SHOULDER ARTHROPLASTY CASE, CST [CERTIFIED SURGICAL TECH] 1 NOTICED THAT THE HANEY NEEDLE DRIVER WAS BROKEN. CST 1 WAS NOT SURE OF THE EXACT TIME THAT THE BREAK OCCURRED BUT WAS FAIRLY CERTAIN THAT IT WAS NOT BROKEN AT THE START OF THE CASE. UPON FURTHER INVESTIGATION, CST 1 LOCATED THE BROKEN PIECE OF THE NEEDLE DRIVER INSIDE THE OF THE SURGICAL INCISION. THE BROKEN PIECE WAS REMOVED, THOROUGHLY INSPECTED TO ENSURE NO ADDITIONAL PIECES REMAINED MISSING, AND PASSED OFF THE FIELD TO RN CIRCULATOR 1. THE INCISION WAS THEN IRRIGATED COPIOUSLY.