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U.S. Department of Health and Human Services

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

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MEDLINE RENEWAL SMITH & NEPHEW DYONICS 3.5 INCISOR SHAVER, ARTHOSCOPIC (ORIGINAL MANUFACTURER) ARTHROSCOPE Back to Search Results
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).
 
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Brand NameSMITH & NEPHEW DYONICS 3.5 INCISOR SHAVER, ARTHOSCOPIC (ORIGINAL MANUFACTURER)
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
MEDLINE RENEWAL
MDR Report Key11087004
MDR Text Key224401489
Report NumberMW5098547
Device Sequence Number1
Product Code HRX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received12/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200095R
Device Lot Number445279
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 12/28/2020 Patient Sequence Number: 1
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