MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE; FLEX REVIVE LOCKING CAP

Catalog Number ARS655200

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

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

Event Date 10/20/2019

Event Type  malfunction  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.

Event Description

Revive locking caps x2 would not thread into place during this case.Surgeon worked on it for roughly 30 minutes starting over and putting it back together with the same result.The patient needed additional anesthesia to allow for the doctor to finish.

Event Description

Revive locking caps x2 would not thread into place during this case.Surgeon worked on it for roughly 30 minutes starting over and putting it back together with the same result.The patient needed additional anesthesia to allow for the doctor to finish.

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunctioned or is related to a death or injury.- attachment: [comp-2019-2891 investigation summary mdr.Pdf].

• Brand Name: AEQUALIS FLEX REVIVE
• Type of Device: FLEX REVIVE LOCKING CAP
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington, mn MN 55437
• MDR Report Key: 9334774
• MDR Text Key: 191199693
• Report Number: 3004983210-2019-00111
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K181420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2023
• Device Catalogue Number: ARS655200
• Device Lot Number: AZ1218218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR