1.3MM/1.5MM BONE DEPTH GAUGE
Received Jun 5, 2026 · Event occurred May 12, 2026
Report 0001825034-2026-01635 · MDR key 25417738
Device
Product problems
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). D10: ITEM # 231220202, FAST 1.1MM DRILLBIT MINIQUICK , LOT # UNKNOWN. ITEM # 231220209, 1.5MM DRIVER BIT , LOT # UNKNOWN. ITEM # 131220153, 1.5MM LOCK PLATE Y-SHAPE , LOT # UNKNOWN. ITEM # 131220512, NON LOCK SCREW 1.5X12MM , LOT # UNKNOWN. ITEM # 131220411, LOCK SCREW 1.5X11MM , LOT # UNKNOWN. ITEM # 131220413, LOCK SCREW 1.5X13MM , LOT # UNKNOWN. ITEM # 131220410, LOCK SCREW 1.5X10MM , LOT # UNKNOWN. ITEM # 231220104, 1.3MM/1.5MM BONE DEPTH GAUGE , LOT # UNKNOWN. 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.
Description of Event or Problem
IT WAS REPORTED THAT A DEPTH GAUGE BROKE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.