MAUDE Adverse Event Report: UNKNOWN EXTRACTOR

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

It was reported that the patient experienced hardware removal of a synthes tibial nail.During the procedure a piece of the nail broke off and became stuck in a competitor's extractor.The original procedure was performed approximately 15 years ago and the nail was not locked distally or proximally.The patient experienced knee pain and the nail was subsequently discovered to have migrated into the knee joint.Approximately 80% of the nail was left in the tibia.No surgical delays were reported and the procedure was successfully completed.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: EXTRACTOR
• Type of Device: EXTRACTOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17532603
• MDR Text Key: 321143399
• Report Number: MW5139510
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1