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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE POWER-MINI DISP 2.9; ARTHROSCOPE
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SMITH & NEPHEW, INC. INCISOR PLUS ELITE POWER-MINI DISP 2.9; ARTHROSCOPE Back to Search Results
Catalog Number 72201513
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2023
Event Type  Injury  
Event Description
It was reported that during a wrist arthroscopy procedure, unspecified flaws were noted on the incisor plus.The procedure was successfully completed with no surgical delay, applying a change in the surgical technique, an open surgery was performed.No further complications were reported.
 
Manufacturer Narrative
H10: internal complaint reference: (b)(4).
 
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Brand Name
INCISOR PLUS ELITE POWER-MINI DISP 2.9
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key17663348
MDR Text Key322421791
Report Number1219602-2023-01669
Device Sequence Number1
Product Code HRX
UDI-Device Identifier03596010654458
UDI-Public03596010654458
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K172092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 08/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72201513
Device Lot Number51088620
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/10/2023
Date Device Manufactured12/03/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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