• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE; ACCESSORIES, ARTHROSCOPIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARTHREX, INC. SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE; ACCESSORIES, ARTHROSCOPIC Back to Search Results
Model Number SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2022
Event Type  malfunction  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
It was reported on (b)(6) 2022 by a facility representative via sems that an ar-3373-4002 sheaths o-ring is falling apart.This was discovered during a procedure with no patient harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
Type of Device
ACCESSORIES, ARTHROSCOPIC
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key13528117
MDR Text Key288633008
Report Number1220246-2022-04461
Device Sequence Number1
Product Code NBH
UDI-Device Identifier00888867198579
UDI-Public00888867198579
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
Device Catalogue NumberAR-3373-4002
Device Lot Number1575493
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/24/2022
Initial Date FDA Received02/14/2022
Date Device Manufactured11/19/2019
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
-
-