inforMED
MalfunctionHTT

4.0MM BURR

Received Aug 26, 2016 · Event occurred Jul 6, 2016

Report MW5064437 · MDR key 5917209

Device

Generic name

Burr

Manufacturer

Arthrex

Catalog number

AR-84000BE

Lot number

10044031

Product problems

  • Metal Shedding Debris

Patient

50 YR

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

PATIENT UNDERWENT SHOULDER ARTHROSCOPY ON (B)(6) 2016. DURING THE PROCEDURE, METAL SHAVINGS WERE RELEASED WHEN THE BURR WAS USED. THE EQUIPMENT WAS SENT BACK TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO ADVERSE IMPACT TO THE PATIENT TO DATE.