MAUDE Adverse Event Report: ARTHREX, INC. 9.5 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 9.5 MM FLIP CUTTER II

Device Problems Break (1069); Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 08/23/2016

Event Type  Injury  

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.

Event Description

It was reported that a female patient had surgery on her left knee.The patient suffered cruciate ligament rupture - anterior cruciate ligament and also had crackings of the inner meniscus horn due to a sportive accident.The surgery took place on the (b)(6) 2016.During that surgery the tip of arthex device - ar-1204af-95 broke off inside the patient which was not noticed by the surgeon.The surgeon got aware of this post-op when a x-ray and a computer tomography of the knee was performed.Also it was noticed that the femoral drill channel was not deep enough.Thats why the surgeon decided to perform a revision surgery.The revision surgery took place on the (b)(6) 2016 in the same hospital with the same medical staff.The arthrex device ar-1204af-100 was used this time.During the procedure the tip of the device broke again.(b)(4).At the moment arthrex is not informed if the broken tip fragment was retrieved immediately.Post op of the revision surgery the patient went to see another doctor in another hospital to get a neutral opinion.This doctor then determined that a partial rupture of the cruciate ligament plasty and also in addition a meniscus damage had occurred due to the maltreatment of the previous surgeon.Thats why another revision took place on the (b)(6) 2017.The 3rd surgery was performed by the second visited surgeon.At the moment arthrex (b)(4) does not have more information.Further questions are asked.

• Brand Name: 9.5 MM FLIP CUTTER II
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 8674164
• MDR Text Key: 147169476
• Report Number: 1220246-2019-01134
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867004276
• UDI-Public: 00888867004276
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 9.5 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-95
• Device Lot Number: 605562617
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR