MAUDE Adverse Event Report: TORNIER INC. AEQUALIS PERFORM REVERSE SHOULDER SYSTEM; SHOULDER PROSTHESIS BASEPLATE REAMER

Catalog Number MWJ109

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 06/29/2018

Event Type  malfunction  

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.

Event Description

It was reported that during surgery, the surgeon said that the 029mm and 025mm reamers would not cut.Another set had to be opened to complete the surgery.The surgery time was extended by about 15 minutes requiring additional anesthesia to keep the patient stable.

• Brand Name: AEQUALIS PERFORM REVERSE SHOULDER SYSTEM
• Type of Device: SHOULDER PROSTHESIS BASEPLATE REAMER
• Manufacturer (Section D): TORNIER INC.; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: matt kennedy ; 10801 nesbitt ave s; bloomington, MN 55437 ; 9526837482
• MDR Report Key: 7730085
• MDR Text Key: 115372352
• Report Number: 3004983210-2018-00038
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MWJ109
• Device Lot Number: CV0217206
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention