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

Model Number KNEE SCORPION

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

On 4th march 2024, it was reported by a sales rep.Via email that for an (b)(4), (knee scorpion¿), the needle broke in the scorpion as it was being fired to pass the suture.This was detected during use in a meniscal root repair procedure on (b)(6) 2024 and the procedure was completed successfully.This needle was removed and a new needle was placed into the device, but this needle subsequently broke as well.(b)(6) 2024 - the sales rep.Replied that the procedure was completed successfully as a new scorpion was opened from another set and this scorpion did not break the needle.The defect with the device was that it appeared to have a tightness in the shaft where the needle passed.This friction created led to the needle breaking.The needle snapped and was then dislodged into the knee, as it was around 2-2.5cm long it was easily recovered.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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: jared engle ; 8009337001
• MDR Report Key: 18896288
• MDR Text Key: 337577760
• Report Number: 1220246-2024-01443
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867196322
• UDI-Public: 00888867196322
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/13/2024

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: 15104165A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1