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

Catalog Number AR-13995N

Device Problems Break (1069); Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/14/2015

Event Type  Injury  

Manufacturer Narrative

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.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.A buckled needle and broken needle point was found during our evaluation.The needle has an irregular curve due to the buckling.The nitinol surface at the distal end of the needle demonstrates minimal scrape marks, indicating the device was not fired excessively.The suture passing test could not be performed due to the buckled needle and broken needle point.The mating part (instrument) used in the event was not returned.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.This is the second 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.

Event Description

It was reported that the surgeon was performing a rotator cuff procedure and the needle tip broke mid-way through the procedure.They took an x-ray and it revealed about 2 to 3 mm of the tip was left in the patient.Surgeon stated the tip was embedded in the tissue and could not retrieve it.Follow-up investigation: the surgeon was passing one of the sutures through the rotator cuff and the tip of the needle was discovered missing when the needle was pulled out.Surgeon tied a knot to secure the sutures and then proceeded with the planned lateral anchor.After the procedure was finished the surgeon attempted to locate the needle tip for removal but was unable to locate it.The tip is believed to be located in the middle of the rotator cuff tissue.

• Brand Name: 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: 5203863
• MDR Text Key: 30458285
• Report Number: 1220246-2015-00293
• Device Sequence Number: 1
• Product Code: MDM
• 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,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/15/2015

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: 07/01/2020
• Device Catalogue Number: AR-13995N
• Device Lot Number: 1200060Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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: 50 YR