MAUDE Adverse Event Report: MEDLINE RENEWAL SMITH & NEPHEW DYONICS 3.5 INCISOR SHAVER, ARTHOSCOPIC (ORIGINAL MANUFACTURER); ARTHROSCOPE

Model Number 72200095R

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/23/2020

Event Type  Injury  

Event Description

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).

• Brand Name: SMITH & NEPHEW DYONICS 3.5 INCISOR SHAVER, ARTHOSCOPIC (ORIGINAL MANUFACTURER)
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDLINE RENEWAL
• MDR Report Key: 11087004
• MDR Text Key: 224401489
• Report Number: MW5098547
• Device Sequence Number: 1
• Product Code: HRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 72200095R
• Device Lot Number: 445279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR