MAUDE Adverse Event Report: ARTHREX INC. REAMER, LOW PROFILE; REAMER, ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number AR-1410LP

Device Problems Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 02/11/2021

Event Type  malfunction  

Event Description

A 10 mm low profile reamer tip shredded in knee upon drilling.

• Brand Name: REAMER, LOW PROFILE
• Type of Device: REAMER, ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX INC.
• MDR Report Key: 11358090
• MDR Text Key: 233266447
• Report Number: MW5099526
• Device Sequence Number: 1
• Product Code: HTO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AR-1410LP
• Device Lot Number: 12116875
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR