InjuryHRX
SMITH & NEPHEW DYONICS 3.5 INCISOR SHAVER, ARTHOSCOPIC (ORIGINAL MANUFACTURER)
Received Dec 28, 2020 · Event occurred Dec 23, 2020
Report MW5098547 · MDR key 11087004
Device
Product problems
- Break
Patient
59 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WHILE USING SHAVER IN ARTHROSCOPIC SHOULDER SURGERY, THE TEETH ON THE SHAVER BROKE OFF. THE IS A REPROCESSED PRODUCT. TEETH RETRIEVED DURING PROCEDURE AND ORIGINAL PRODUCT FROM SMITH AND NEPHEW OPENED TO THE STERILE FIELD FOR THE REMAINDER OF THE SURGERY. SMITH & NEPHEW, (B)(4). FDA SAFETY REPORT ID # (B)(4).