MAUDE Adverse Event Report: TORNIER INC AEQUALIS¿ PERFORM REVERSED; BIT, SURGICAL

Catalog Number MWJ127

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the device is anticipated.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the driver snapped when the surgeon was finishing the procedure.There was no delay to surgery nor was there impact to the patient.

Manufacturer Narrative

The reported event was confirmed with the help of image provided, which matches to the alleged failure.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.However, one of the probable causes of the event could be breakage due to excessive force application.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text: device not available.

Event Description

It was reported that the driver snapped when the surgeon was finishing the procedure.There was no delay to surgery nor was there impact to the patient.

• Brand Name: AEQUALIS¿ PERFORM REVERSED
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12661499
• MDR Text Key: 282112915
• Report Number: 3004983210-2021-00069
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00846832062492
• UDI-Public: 00846832062492
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MWJ127
• Device Lot Number: CR0118346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1