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 Device Embedded In Tissue or Plaque (3165)

Event Date 01/09/2020

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 meniscal repair procedure, the scorpion needle, ar-12990n, tip broke in the joint of the patient.The surgeon tried to retrieve all visible broken fragments, however, the surgeon could not confirm if he had retrieved all of the broken fragments.No further information provided.Additional information provided 1/28/2020: the case was completed by using the same device, as the device broke in the last pass and the surgeon was able to sew with no issue.

Manufacturer Narrative

This is a duplicate of the original submission.This follow up report was generated in error.The original report stands as it is with no device returns so no device evaluation.

• 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: 9659103
• MDR Text Key: 188655560
• Report Number: 1220246-2020-01642
• 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: 03/27/2020

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: 05/31/2024
• Device Model Number: SCORPION NEEDLE, KNEE
• Device Catalogue Number: AR-12990N
• Device Lot Number: 10326088
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other