MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. HUNTER; SPATULA, ORTHOPEDIC

Model Number TR500000

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

It was reported that the patient underwent a surgical procedure with a hunter tendon rod being implanted.The surgeon took x-rays 9 days post-op and the rod was intact and where it should be.Allegedly, 3 months post-op the surgeon again took x-rays in preparation for the second phase of the surgery.The surgeon noticed the rod had broken with approximately 1 cm still attached distally and the other portion of the rod had migrated 2 cm.

• Brand Name: HUNTER
• Type of Device: SPATULA, ORTHOPEDIC
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer Contact: 1023 cherry road; 901451-631
• MDR Report Key: 7048777
• MDR Text Key: 93199823
• Report Number: 1043534-2017-00112
• Device Sequence Number: 1
• Product Code: HXR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K853436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TR500000
• Device Lot Number: 1593246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/26/2017
• Event Location: Outpatient Diagnostic Facility
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR