INTEGRA® JARIT®
Received Dec 8, 2025 · Event occurred Oct 6, 2025
Report 23735743 · MDR key 23735743
Device
Generic name
Twister, Wire
Manufacturer
Integra Lifesciences Production CorporationModel number
121260Catalog number
121-260
Product problems
- Break
Patient
75 YR · Female
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY [REDACTED DATE]. POST-OP IMAGING NOTED A RETAINED FOREIGN BODY. THE PATIENT RETURNED TO THE OR ON [DATE REDACTED] - THE NEXT DAY - FOR REMOVAL OF THE RETAINED ITEM, WHICH WAS NOTED TO BE A PIECE OF THE NEEDLE HOLDER. THE AFFECTED NEEDLE HOLDER HAS BEEN LOCATED AND REMOVED FROM SERVICE. THE NEEDLE HOLDER BROKE OFF WITHIN THE PATIENT DURING THA REQUIRING AN ADDITIONAL PROCEDURE TO REMOVE. DEVICE IDENTIFIERS JARIT OR INTEGRA-JARIT #121-260 TUNGSTEN CARBIDE CARB-BITE NEEDLE HOLDER 7.5." OTHER IDENTIFIERS ON THE INSTRUMENT INCLUDE: [REDACTED]. MAY ALSO BE KNOWN AS MAYO-HEGAR NEEDLE HOLDER.