MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX FLIPCUTTER; REAMER - ORTHOPEDIC MANUEL INSTRUMENT

Device Problems Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/15/2019

Event Type  malfunction  

Event Description

Arthrex flip cutter, disintegrated during a knee arthroscopy.The surgeon felt "100% sure" that all pieces were removed.However a f/u xray in his office a week later showed a piece had been left behind.The pt had to return to surgery to have it removed.Fda safety report id# (b)(4).

• Brand Name: ARTHREX FLIPCUTTER
• Type of Device: REAMER - ORTHOPEDIC MANUEL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.
• MDR Report Key: 8712012
• MDR Text Key: 148476617
• Report Number: MW5087432
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• 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?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 YR