MalfunctionHTT
STRYKER
Received Oct 1, 2021 · Event occurred Aug 23, 2021
Report 12561558 · MDR key 12561558
Device
Generic name
Burr, Orthopedic
Manufacturer
ProvisionModel number
1607-002-107Catalog number
1607-002-107
Lot number
21109017
Product problems
- Break
Patient
10585 DA
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
INTRAOPERATIVE, PHYSICIAN STATED THAT THE TIP OF A STRYKER 1.6MM TAPER SIDE CUTTING CARBIDE BUR (REF# (B)(4), LOT # 21109017, EXP 04/01/2026) BROKE OFF IN THE PATIENT'S BONE DURING A MAXILLOFACIAL SURGERY. THE TIP OF THE BUR WAS RETRIEVED OUT OF THE BONE BY PHYSICIAN.