MAUDE Adverse Event Report: ARTHREX, INC. RING CURRETTE,ANKLE ARTHRSCPY,REVSE ANGL; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number RING CURRETTE,ANKLE ARTHRSCPY,REVSE ANGL

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/27/2023

Event Type  malfunction  

Event Description

On 1/30/2023 it was reported by a sales representative via sems that an ar-8655-04 ring currette broke off inside the patient during the ankle arthroscopy/micro fracture repair.The tip of curette broke off inside the joint when trying to remove loose cartilage during the middle of the arthroscopy procedure.The surgeon had to open laterally since he was not able to retrieve the piece inside the joint.They used fluro to located the broken piece but still the surgeon never retrieved the broken piece.

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.

• Brand Name: RING CURRETTE,ANKLE ARTHRSCPY,REVSE ANGL
• 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: 16403787
• MDR Text Key: 310161768
• Report Number: 1220246-2023-06325
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867044272
• UDI-Public: 00888867044272
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RING CURRETTE,ANKLE ARTHRSCPY,REVSE ANGL
• Device Catalogue Number: AR-8655-04
• Device Lot Number: 1391844
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2023
• Date Device Manufactured: 12/07/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1