MAUDE Adverse Event Report: ARTHREX, INC. KNEE SCORPION; MANUAL INSTR, GENERAL SURGICAL

Model Number KNEE SCORPION

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2023

Event Type  malfunction  

Event Description

On 8/31/2023, it was reported by a sales representative via sems-06019754 that an ar-12990 knee scorpion was struggling to get through the meniscus, and the tip of the needle broke off and was retrieved.A second needle was used, and it broke off inside and became stuck.This was discovered during an unspecified procedure, with no reported patient harm.Additional information received on 9/11/2023: this was discovered during a meniscal root repair procedure on (b)(6) 2023.The second needle broke inside the scorpion with no fragments lost inside the patient.The case was completed utilizing the suture passing needle and a fibersnare.The surgeon fed the needle up the bone tunnel and penetrated the meniscus.There was no reported delay in the procedure.The product and batch number for the needles that were used for the ar-12990 knee scorpion were not recorded.

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.

Manufacturer Narrative

Complaint is confirmed.Functional testing found that the device has a needle stuck inside the shaft of the scorpion.Visual inspection noted no problems with the device.The most likely cause is attributed to misuse due to use error.Dfu-0392-sub-eo warns against the usages listed to help avoid needle breakage and potential patient injury.Refer to the investigation photo.

• Brand Name: KNEE SCORPION
• Type of Device: MANUAL INSTR, GENERAL SURGICAL
• 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: emily shafer ; 8009337001
• MDR Report Key: 17837396
• MDR Text Key: 324515513
• Report Number: 1220246-2023-08016
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867196322
• UDI-Public: 00888867196322
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

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: KNEE SCORPION
• Device Catalogue Number: AR-12990
• Device Lot Number: 15019087
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1