MalfunctionGDJ
MILLENNIUM SURGICAL CORP
Received Mar 23, 2026 · Event occurred Jan 26, 2026
Report 3004215117-2026-00001 · MDR key 24670144
Device
Generic name
Meniscal Clamp W Teeth
Manufacturer
Millennium Surgical CorpModel number
1-1883Lot number
A407
Product problems
- Material Fragmentation
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A COMPLAINT FROM CUSTOMER PLUM CREEK SURGERY CENTER FOR ONE (1) UNIT OF ITEM #1-1883 FROM LOT A407. A TOOTH BROKE OFF DURING NORMAL SURGERY INTRA-OP USE ON (B)(6) 2026. THERE WAS NO DEATH OR SERIOUS INJURY. THERE WAS NO PATIENT INTERVENTION. THE CONDITION OF THE PATIENT WAS FINE. THERE WAS A DELAY OF TWENTY MINUTES WITH NO IMPACT TO THE PATIENT. THE BROKEN TOOTH WAS RETRIEVED.