inforMED
MalfunctionKWS

EX UNKNOWN REAMERS

Received Jun 30, 2026 · Event occurred Mar 3, 2026

Report 0001825034-2026-01940 · MDR key 25669489

Device

Generic name

Bone-resection Orthopaedic Reamer, Reusable

Catalog number

UNKNOWN

Lot number

UNKNOWN

Product problems

  • Naturally Worn

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT TWO REAMERS WORE OUT WHILE PREPARING THE GLENOID FOR BASE PLATE PLACEMENT DUE TO EXISTING METAL ANCHORS IN THE GLENOID. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). D10: ITEM # 110029136, COMPR RVS BSPLT RMR 25MM SHORT, LOT # 65699472. H6: PROPOSED COMPONENT CODE, MECHANICAL (G04), DRILL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.