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

Device Problems Break (1069); Crack (1135); Noise, Audible (3273)

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

Event Date 11/14/2022

Event Type  malfunction  

Event Description

Arthrex flipcutter iii drill was broken, did not engage blade while inside patient's joint.A new device was obtained and used.Per or note: preoperative diagnosis.Left anterior cruciate ligament tear with possible medial meniscus tear and medial collateral ligament tear.Complications: breakage of the flipcutter iii device on initial drilling.No retained fragments of the implant.No patient's sequelae from the breakage.We drilled our femoral tunnel with the flipcutter device.During the initial drilling, one of the flipcutter iii devices broke and we were unable to fully retract the device or complete our drilling.Fortunately, the device was fully intact with no displaced fragments and one of the small arms that allowed for retraction of the blade had cracked in its midportion, but both fragments of the arm were intact.We were able to remove the flipcutter and then passed a new one completing our drilling.Per the surgeon: the device has a retractable blade to adjust the diameter of the hole being drilled.About 5mm into drilling, i heard a small pop/crack and the feel of the drill changed.One of the arms/hinges on the adjustable blade had broken but we were able to remove it intact and complete the case without any additional issues beyond the lost time.I have never had this happen before, but i have heard of it anecdotally from other institutions about an older version of the flipcutter (which doesn¿t have the retractable arm).

• Brand Name: FLIPCUTTER III DRILL
• Type of Device: REAMER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 15904310
• MDR Text Key: 304687842
• Report Number: 15904310
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5840 DA
• Patient Sex: Male