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

Catalog Number AR-12990N-1

Device Problems Bent (1059); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) 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.The device was requested/is expected for evaluation but has not yet been received.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.

Event Description

It was reported that the needle would not pass trough the meniscus during meniscal root repair.Both needles bent in the same place - 2 cm from the distal tip.Device was firing correctly when outside the joint.The surgeon had to change the surgical technique to a meniscectomy.With the changed technique, the surgery was completed successfully.No implant was used at the end.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) 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.This is a follow-up submission due to device evaluation.A precise cause for buckled needle strips on the knee scorpion needles could not be determined.This failure mode is typically caused by applying excessive force while attempting to pass through challenging tissue (i.E thick or calcified).The end user applied forces will cause the needle to buckle within the cannulation of the hand instrument and produce a buckled "s" shaped failure mode.The mating part (instrument) used during the event was not returned along with complaint devices.Confirmed the needle strips thickness and width dimensions to be within specifications.This is the first complaint of this type for this part/ lot combination.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.

Event Description

It was reported that the needle would not pass trough the meniscus during meniscal root repair.Both needles bent in the same place - 2 cm from the distal tip.Device was firing correctly when outside the joint.The surgeon had to change the surgical technique to a meniscectomy.With the changed technique, the surgery was completed successfully.No implant was used at the end.

• Brand Name: SCORPION NEEDLE, KNEE
• 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, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7178417
• MDR Text Key: 96851232
• Report Number: 1220246-2017-00508
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867266520
• UDI-Public: 00888867266520
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Catalogue Number: AR-12990N-1
• Device Lot Number: 10067240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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