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

Model Number SUREFIRE SCORPION NEEDLE

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was 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 during a rcr (rotator cuff repair) procedure, the tip of the scorpion needle, ar-13991n, broke.An x-ray was taken and confirmed that the needle tip was left in the patients shoulder.Additional information provided 5/28/2019: the case was completed with a new needle.The surgeon looked for the tip before continuing.This needle tip may have broken on the upper jaw, as even though the jaws were held tight, the needle was having trouble passing.

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 distorting distally under the jaw.The mating (instrument) was not returned or identified.Confirmed the needle strip thickness and width dimensions to be within specification.

• Brand Name: SUREFIRE SCORPION NEEDLE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8669938
• MDR Text Key: 147036385
• Report Number: 1220246-2019-01131
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015920
• UDI-Public: 00888867015920
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

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 Expiration Date: 06/30/2023
• Device Model Number: SUREFIRE SCORPION NEEDLE
• Device Catalogue Number: AR-13991N
• Device Lot Number: 10221765
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 05/16/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other