MAUDE Adverse Event Report: ARTHREX, INC. SUREFIRE SCORPION NEEDLE/MULTIFIRE SCORPION NEEDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number AR-13995N

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/31/2016

Event Type  Injury  

Manufacturer Narrative

Patient demographics (date of birth) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Device history record review revealed nothing relevant to this event.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The typical cause for this type of event is the use of excessive force to pass the needle through thick or hard tissue or hitting bone with the needle.There is a label on the device warning the user against re-sterilizing, reusing, hitting bone or use of excessive force as these may result in needle breakage or patient injury.This is the (b)(4) complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Per reporter device not available.

Event Description

It was reported by the facility via a facility medwatch copy that a patient was having a left shoulder rotator cuff tear repair/massive and left shoulder spontaneous proximal biceps tear repair with distal retraction procedure on (b)(6) 2016.The surgeon was using a disposable arthrex multifire scorpion needle, ar-13995n, when the tip of the scorpion needle broke off inside the rotator cuff.The tip was visualized in the field with c-arm.The surgeon tried to remove the needle tip but could not.Facility confirmed that surgeon noted the risk of removing the tip outweighed the benefit so he opted to leave it within the rotator cuff tissue.The small piece of metal from the needle is about a millimeter.To complete the case the surgeon tethered the cuff and attached it to the bone.

• Brand Name: SUREFIRE SCORPION NEEDLE/MULTIFIRE SCORPION 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, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337017
• MDR Report Key: 6025438
• MDR Text Key: 57262268
• Report Number: 1220246-2016-00420
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: 00888867015951
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: AR-13995N
• Device Lot Number: 10017189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 81