MAUDE Adverse Event Report: ARTHREX, INC. 9.0 MM FLIP CUTTER II; MANUAL INSTR, GENERAL SURGICAL

Model Number 9.0 MM FLIP CUTTER II

Device Problem Defective Device (2588)

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

Event Date 12/12/2023

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 anterior cruciate ligament surgery, when drilling the tibia, the flipcutter performed well drilling forward.It flipped to 90 degrees inside the joint.However, when drilling backwards the doctor said it didn't feel right.When he advanced forward into the joint the flip was no longer at 90 degrees.He did this two more times with same result.The flipcutter was placed inside the drill with enough room on the stem so it would flip properly.There was no harm for patient, operator or third party.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: 9.0 MM FLIP CUTTER II
• Type of Device: MANUAL INSTR, GENERAL SURGICAL
• 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: 18474094
• MDR Text Key: 332427724
• Report Number: 1220246-2024-00206
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867004269
• UDI-Public: 00888867004269
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 01/09/2024

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: 9.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-90
• Device Lot Number: 3191133214
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2023
• 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