MAUDE Adverse Event Report: TORNIER INC AEQUALIS PERFORM REVERSE SHOULDER SYSTEM; SHOULDER PROSTHESIS CENTRAL SCREW 6.5 X 35MM

Catalog Number DWJ535

Device Problems Positioning Problem (3009); Difficult or Delayed Separation (4044)

Patient Problem No Code Available (3191)

Event Date 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during implantation, dr.(b)(6) that the 6.5 mm diameter central screw was too thin.Therefore, she wanted to replace this screw with a diameter of 9.5 mm.The 6.5 mm screw could not be removed from the baseplate (left-hand thread was considered).Surgery time was extended by over 60 minutes.

Event Description

It was reported that during implantation, dr.(b)(6) found that the 6.5 mm diameter central screw was too thin.Therefore, she wanted to replace this screw with a diameter of 9.5 mm.The 6.5 mm screw could not be removed from the baseplate (left-hand thread was considered).Surgery time was extended by over 60 minutes.

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.

• Brand Name: AEQUALIS PERFORM REVERSE SHOULDER SYSTEM
• Type of Device: SHOULDER PROSTHESIS CENTRAL SCREW 6.5 X 35MM
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• MDR Report Key: 8664365
• MDR Text Key: 146949838
• Report Number: 3004983210-2019-00021
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

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 Expiration Date: 05/29/2023
• Device Catalogue Number: DWJ535
• Device Lot Number: AZ0817354
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FULL WEDGE AUGMNT BASEPLATE (DWJ505); FULL WEDGE AUGMNT BASEPLATE (DWJ505)
• Patient Outcome(s): Required Intervention