MAUDE Adverse Event Report: ARTHREX INC. ARTHREX LOW PROFILE REAMER

Model Number AR-1410LP

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/17/2018

Event Type  Injury  

Event Description

During an acl recontruction, a piece of a flute of a low profile reamer broke off and was retained inside of a pt.Determined to not be related to user error.

• Brand Name: ARTHREX LOW PROFILE REAMER
• Type of Device: REAMER
• Manufacturer (Section D): ARTHREX INC. ; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 8074297
• MDR Text Key: 127352514
• Report Number: MW5081280
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-1410LP
• Device Catalogue Number: 055529
• 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: 28 YR
• Patient Weight: 57