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

Model Number	SUREFIRE SCORPION NEEDLE
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the tip of needle broke-off during a rotator cuff shoulder procedure.No harm for patient, operator or third party was reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique.On 03-jun-2019 update: broken tip of needle was not retrieved from patient.It remains in patient.
Additional 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 distal end of the nitinol 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: SUREFIRE SCORPION NEEDLE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8735883
• Report Number: 1220246-2019-01158
• Device Sequence Number: 2637268
• Product Code: MDM
• UDI-Device Identifier: 00888867283978
• UDI-Public: 00888867283978
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: SUREFIRE SCORPION NEEDLE
• Device Catalogue Number: AR-13991N-1
• Device Lot Number: 10279320
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other