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

Catalog Number AR-13995N

Device Problems Bent (1059); Break (1069); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/16/2016

Event Type  Injury  

Manufacturer Narrative

Patient demographics (date of birth, 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 report two of three separate reports for this event.The other reports are cc84839 line 156561 (1220246-2016-00151) and cc84839 line 156596 (1220246-2016-00153).The device was requested/is expected for evaluation but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.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 first complaint of this type for this part/lot combination.The potential cause(s) of this event will be 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 during a rotator cuff repair, the surgeon was passing the first suture of the fibertape which worked fine.Upon passing through the second suture, it was not passing through and surgeon pulled hard on the suture breaking the tip of the needle.The first needle was broken outside the patient field.A second needle was opened and when passing it the tip bent, but did not break.A third needle was opened and fired and the device tip broke.The tip was not found and may remain in the patient.It is unknown which lot was used first, second or third.(lot 401024 line 156595, lot 400607 line 156561, lot 10011309 line 156596).Surgeon converted to a mini open repair and used #2 fiberwire to complete the case.The rep states the surgeon elected to not perform an x-ray because he felt confident all pieces were removed via the repeated irrigation and suction during the mini open and because he could visibly see after he converted to the mini open.

Manufacturer Narrative

Patient demographics (date of birth, 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 to reflect the device evaluation.This is report two of three separate reports for this event.The other reports are cc84839 line 156561 (1220246-2016-00151fu1) and cc84839 line 156596 (1220246-2016-00153fu1).Complaint confirmed for a broken needle point.The distal end of the nitinol point demonstrated minimal scrape marks, indicating the device was not fired excessively.The buckled needle strip condition is typically caused by the device skiving under thick tissue or distorting distally under the jaw.The instrument used in the event was not returned or identified.The strip thickness, and width dimensions were confirmed to be within specification.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 first complaint of this type for this part/lot combination.The potential cause(s) of this event will be 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 during a rotator cuff repair, the surgeon was passing the first suture of the fibertape which worked fine.Upon passing through the second suture, it was not passing through and surgeon pulled hard on the suture breaking the tip of the needle.The first needle was broken outside the patient field.A second needle was opened and when passing it the tip bent, but did not break.A third needle was opened and fired and the device tip broke.The tip was not found and may remain in the patient.It is unknown which lot was used first, second or third.(lot 401024 line 156595, lot 400607 line 156561, lot 10011309 line 156596).Surgeon converted to a mini open repair and used #2 fiberwire to complete the case.The rep states the surgeon elected to not perform an x-ray because he felt confident all pieces were removed via the repeated irrigation and suction during the mini open and because he could visibly see after he converted to the mini open.

• 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: 5548228
• MDR Text Key: 41919432
• Report Number: 1220246-2016-00152
• 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: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Catalogue Number: AR-13995N
• Device Lot Number: 401024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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: 61 YR