inforMED
MalfunctionMDM

SCORPION-MULTIFIRE NEEDLE

Received Apr 9, 2026 · Event occurred Feb 4, 2026

Report 1220246-2026-02112 · MDR key 24834012

Device

Generic name

Manual Instr, General Surgical

Manufacturer

Arthrex, Inc.

Catalog number

AR-13995N

Lot number

15505545

Product problems

  • Break

Patient

NA · Unknown

  • Foreign Body In Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING THE SHOULDER SURGERY, THE TIP OF THE NEEDLE BROKE OFF AND REMAINED IN THE PATIENT´S SHOULDER. NO FURTHER INFORMATION WAS RECEIVED. UPDATE 19-MAR-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE ROTATOR CUFF SURGERY, THE TIP OF THE NEEDLE BROKE OFF AND REMAINED IN THE PATIENT´S SHOULDER. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.