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 Device Embedded In Tissue or Plaque (3165)

Event Date 03/17/2020

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 during a rotator cuff repair procedure the tip of the ar-13995n, multifire scorpion needle broke off after one singular fire.The rep reported there was no abnormal tissue.The needle tip was lodged into the cuff tissue and unable to be recovered.Additional information has been requested.Additional information received on 04/03/2020: the sales rep reported the surgeon spent over 20 minutes trying to recover the broken needle tip, including x-ray use.No unplanned incisions were necessary.A second ar-13995n from the same lot was used to complete the procedure with a full rotator cuff repair using normal technique.The complaint device was discarded and will not be returning for evaluation.The rep reported at this time the surgeon does not plan to perform a second surgery.

• 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: 9935342
• MDR Text Key: 186809704
• Report Number: 1220246-2020-01779
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: 00888867015951
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/07/2020

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 Model Number: SCORPION-MULTIFIRE NEEDLE
• Device Catalogue Number: AR-13995N
• Device Lot Number: 10516579
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other