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

Catalog Number MWJ127

Device Problems Break (1069); Fracture (1260)

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

Event Date 01/05/2022

Event Type  malfunction  

Event Description

It was reported that the driver broke during surgery.No patient complications were reported.A different driver was used to complete the case.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

Event Description

It was reported that the driver broke during surgery.No patient complications were reported.A different driver was used to complete the case.

• 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: 13428675
• MDR Text Key: 288851509
• Report Number: 3004983210-2022-00009
• 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: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: CR0119035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 02/02/2022
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2019
• 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