• 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. SUREFIRE SCORPION NEEDLE; MANUAL INSTR, GENERAL SURGICAL

  • 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. SUREFIRE SCORPION NEEDLE; MANUAL INSTR, GENERAL SURGICAL Back to Search Results
Model Number SUREFIRE SCORPION NEEDLE
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2024
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
On 3/22/2024, it was reported by a sales representative via sems-06522389 that an ar-13991n surefire scorpion needle tip broke off during use with no pieces breaking inside the patient.The case was completed with no further information provided.This was discovered during a rotator cuff repair procedure on (b)(6) 2024, with no reported patient harm.Additional information received on 4/9/2024: an fda medwatch notification was received via email.A facility administrator/supervisor reported that an ar-13991n surefire scorpion needle was used during an arthroscopy of the left shoulder with decompression and rcr procedure on (b)(6) 2024.The needle tip broke off while in use in the patient.The broken fragment could not be located so an x-ray was performed to ensure no foreign body was retained.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUREFIRE SCORPION NEEDLE
Type of Device
MANUAL INSTR, GENERAL SURGICAL
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
jared engle
8009337001
MDR Report Key19127147
MDR Text Key340407951
Report Number1220246-2024-02096
Device Sequence Number1
Product Code MDM
UDI-Device Identifier00888867015920
UDI-Public00888867015920
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 Other,User Facility,Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 04/17/2024
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 NumberSUREFIRE SCORPION NEEDLE
Device Catalogue NumberAR-13991N
Device Lot Number15076401
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/22/2024
Initial Date FDA Received04/17/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/04/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-