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

Model Number SCORPION-MULTIFIRE NEEDLE

Device Problems Break (1069); Entrapment of Device (1212); Failure to Advance (2524)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/09/2018

Event Type  Injury  

Manufacturer Narrative

The device was requested for evaluation but was not returned therefore the complainant's event could not be verified.The device was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.The typical cause for this type of event would be 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.

Event Description

It was reported that during a right rcr procedure, after 3 successful passes, the scorpion multifire needle would not advance through rotator cuff.On the 4th pass, the device was taken out of the cannula and inspected.At this time, it was noticed the needle broke off at the recess point.An x-ray was brought in and it showed the broken piece was lodged inside of the patient¿s tendon.After attempting to find the needle tip with no success, it was left inside the patient.The rep noted that calcified bone from previous injections was observed on the outer and under surface of the patient's rotator cuff.Patient is female, (b)(6).

• 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 Key: 8030556
• MDR Text Key: 125902688
• Report Number: 1220246-2018-00725
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: SCORPION-MULTIFIRE NEEDLE
• Device Catalogue Number: AR-13995N
• Device Lot Number: 10225311
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2018
• 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: 83 YR