MAUDE Adverse Event Report: ARTHREX FLIPCUTTER II DRILL; REAMER

Device Problem Material Separation (1562)

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

Event Date 04/01/2022

Event Type  malfunction  

Event Description

An arthrex flipcutter device was placed in the patient's left knee during acl reconstruction surgery and the orthopedic surgery fellow was advancing the drill guide with a mallet and while doing so struck the external portion of the flipcutter causing it to come apart when the drill was activated.Surgery stopped and all pieces of instrument were retrieved.An intra-operative x-ray was obtained and read by radiologist as negative for retained pieces of instrument.Surgery continued and completed.Patient transported to pacu without any difficulty.

• Brand Name: FLIPCUTTER II DRILL
• Type of Device: REAMER
• Manufacturer (Section D): ARTHREX; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 15629353
• MDR Text Key: 301980834
• Report Number: 15629353
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8395 DA
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: White