MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX FLIPCUTTER III DRILL; REAMER

Model Number AR-1204FF

Patient Problems Fall (1848); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Hyperextension (4523); Swelling/ Edema (4577)

Event Date 02/15/2024

Event Type  Injury  

Event Description

While dr.Was performing a right knee acl repair, arthrex flipcutter iii drill broke while inside the patient.Two pieces were removed from the joint and a post-op xray was obtained to confirm all debris was retrieved.Arthrex rep.Was present for the case providing guidance on proper use of the equipment.One year out from right knee acl tear.He treated this conservatively and did quite well.Reports that he was in his usual state of health till he was backing down a ladder.The fall from the ladder he is unsure whether the knee gave way causing him to fall or if the fall caused his knee to hurt.In any event he felt the knee hyperextend, did not feel a pop at this time that we did 12 months ago.Pain, discomfort, swelling, stiffness ever since the injury.Presents now for evaluation and management.Was seen in the emergency room where x-rays were negative.We discussed results of his second mri imaging which does show further tearing of the acl not categorized as complete.

• Brand Name: ARTHREX FLIPCUTTER III DRILL
• Type of Device: REAMER
• Manufacturer (Section D): ARTHREX, INC.; naples FL 34108
• MDR Report Key: 18768221
• MDR Text Key: 336268837
• Report Number: MW5151866
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-1204FF
• Device Lot Number: 23A70
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Hispanic
• Patient Race: White