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

Model Number SCORPION NEEDLE, KNEE

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

Patient Problem Foreign Body In Patient (2687)

Event Date 09/20/2021

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

On (b)(6) 2021 it was reported by a sales representative via email that an ar-12990n needle broke.This occurred on (b)(6) 2021 during an acl reconstruction and meniscal repair, when the metallic disposable needle of the knee scorpion was found to be broken after passage of sutures 3 times.The needle was noted to be complete before the last suture insertion, but found to be broke after by a nurse.Intra-operative fluoroscopic screening was immediately arranged and completed the broken fragment was found to be embedded within the lateral posterior root stump.Retrieval was no successful despite several attempts without jeopardizing the repair and the anatomical structure.The surgeon decided to leave the broken part in the patient, as it was not found to be producing any part of the knee arthroscopy.The patient was informed about the incident, she will be under regular clinical, and radiological surveillance.

Manufacturer Narrative

Complaint confirmed.Two unpackaged ar-12990n devices were received for investigation.Visual inspection identified breakage at the distal tip of one of the two returned needles.The other needle presented no abnormalities.The needle strip width proximal to the breakage site was assessed using digital micrometer id: 224, and was subsequently identified to meet design specifications.The cause remains undetermined, although a probable cause can be attributed to user-applied mechanical forces or interference between the device and bone/other instrumentation.

• Brand Name: SCORPION NEEDLE, KNEE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12658541
• MDR Text Key: 279927220
• Report Number: 1220246-2021-03804
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867199354
• UDI-Public: 00888867199354
• 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: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCORPION NEEDLE, KNEE
• Device Catalogue Number: AR-12990N
• Device Lot Number: 11864613
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/21/2021
• Patient Sequence Number: 1