MAUDE Adverse Event Report: ARTHREX, INC. NEEDLE, TUOHY WITH OBTURATOR; ARTHROSCOPIC ACCESSORIES

Model Number NEEDLE, TUOHY WITH OBTURATOR

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/28/2023

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

It was reported that, during an autocart procedure, metal debris was found in the harvested cartilage mass.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.09-oct-2023 update dw: further information was provided that after the cartilage is cut with the sabre ar-7300sr and collected with the graftnet it was noticed that no metal particles were found in the cartilage mass at this moment.The metal abrasion only became visible in the joint when the cartilage mass was applied, indicating that the debris was caused by the syringe.The surgeon decided to use the mass with the particles to finish the surgery successfully.

• Brand Name: NEEDLE, TUOHY WITH OBTURATOR
• Type of Device: ARTHROSCOPIC ACCESSORIES
• 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: 18001813
• MDR Text Key: 326462497
• Report Number: 1220246-2023-08348
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867001817
• UDI-Public: 00888867001817
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/25/2023

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: NEEDLE, TUOHY WITH OBTURATOR
• Device Catalogue Number: ABS-1001
• Device Lot Number: 3061129650
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1