• 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. SCORPION-MULTIFIRE NEEDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

  • 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. SCORPION-MULTIFIRE NEEDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Back to Search Results
Model Number SCORPION-MULTIFIRE NEEDLE
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/28/2021
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 that during a procedure, the tip of this needle broke off while trying to pass the suture.The broken tip could never be found and the surgeon believes the fragment was left in the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SCORPION-MULTIFIRE NEEDLE
Type of Device
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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 Key12198291
MDR Text Key264737149
Report Number1220246-2021-03415
Device Sequence Number1
Product Code MDM
UDI-Device Identifier00888867015951
UDI-Public00888867015951
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 07/20/2021
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 NumberSCORPION-MULTIFIRE NEEDLE
Device Catalogue NumberAR-13995N
Device Lot Number12853063
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/01/2021
Initial Date FDA Received07/20/2021
Date Device Manufactured03/05/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-