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 06/17/2022

Event Type  malfunction  

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during a rotator cuff surgery while operating the tip of the scorpion needle broke while taking a suture pass through the supraspinatus tendon.While passing the suture with the scorpion suture passer for arthroscopic rotator cuff repair in the anterior lateral edge of the supraspinatus, the tip of the needle broke.Intra-operative x-rays were taken to locate the tip of the needle.The shoulder joint was scoped thrice inside and out but the needle tip could not be located.Shaver was used in an attempt to suck out the needle tip but it did not appear to be loose and could not be found.The needle tip measured 2mm.An open procedure to locate the needle tip was not performed as this was neither it was a life or limb threatening situation.And that open exploration would have led to further tissue damage of the repaired re-torn tendon, affecting outcome.Duty of candour was completed by explaining the situation to the patient.Post-op x-rays show the needle tip is lying posteriorly and appears to be out of joint.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

The complaint is confirmed based on the customer-provided photo, which displays the broken ar-13995n needle tip.The breakage appears to have occurred proximal to the suture notch feature, which is no longer present at the distal tip.The cause remains undetermined, as the device was not returned for physical inspection.Typical causes for this failure mode include passing the device through thick/challenging tissue, or through hitting bone.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14976020
• MDR Text Key: 303804514
• Report Number: 1220246-2022-05183
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: 00888867015951
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCORPION-MULTIFIRE NEEDLE
• Device Catalogue Number: AR-13995N
• Device Lot Number: 14873512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Date Device Manufactured: 01/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1