MAUDE Adverse Event Report: EXACTECH, INC.; REAMER

Catalog Number 321-25-38

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/27/2019

Event Type  malfunction  

Event Description

The wire tip from the reamer broke off in the patient's bone.

• Type of Device: REAMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 n.w. 66th ct; gainesville FL 32653
• MDR Report Key: 9494855
• MDR Text Key: 171991231
• Report Number: 9494855
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2019,10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 321-25-38
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25915 DA