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

Model Number SCORPION-MULTIFIRE NEEDLE

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

Patient Problem Foreign Body In Patient (2687)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that the tips of two scorpion needles, ar-13995n, were used during a procedure.During use, the tips of both needles broke off during passing of the suture through the cuff.No further details, additional information has been requested.Additional information provided 4/23/2019: the scorpion needles were being used in a greater tuberosity fx/rotator cuff repair procedure.The first needle successfully passed 3-4 times through soft tissue and broke when attempting to go through the fractured bone fragment.The second needle broke on its first attempted pass.The main factor was the surgeon was attempting to pass his suture through the fractured bone fragment, and the scorpion needle was not strong enough.The surgeon completed the case using a suture lasso through the same bone fragment.The two tips were not retrieved as they're embedded within the bone fragment.

Manufacturer Narrative

The failure mode could not be determined, but the broken needle point condition can be caused by consistently passing the needle through challenging tissue (thick or calcified) or hitting bone.The buckled needle strip condition is typically caused by the device skiving under thick tissue or disorting distally under the jaw.The distal end of the nitnol point demonstrated minimal scrape marks, indicating the device was not fired excessively.The mating (instrument) was not returned or identified.Confirmed the needle strip thickness and width dimensions to be within specification.

• 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
• MDR Report Key: 8603148
• MDR Text Key: 144812896
• Report Number: 1220246-2019-01090
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: 00888867015951
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

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 Model Number: SCORPION-MULTIFIRE NEEDLE
• Device Catalogue Number: AR-13995N
• Device Lot Number: 1028489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 04/22/2019
• Supplement Dates FDA Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other