MAUDE Adverse Event Report: TORNIER INC. AEQUALIS PERFORM REVERSE SHOULDER SYSTEM; SHOULDER PROSTHESIS CENTRAL SCREW DRILL

Catalog Number MWJ111

Device Problem Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was noted that during a procedure that a drill bit "broke inside of the patient during use today.The surgeon opted to leave the broken piece of drill inside the patient, however there was a case delay and impact to surgery.".

• Brand Name: AEQUALIS PERFORM REVERSE SHOULDER SYSTEM
• Type of Device: SHOULDER PROSTHESIS CENTRAL SCREW DRILL
• 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: 8195660
• MDR Text Key: 131382545
• Report Number: 3004983210-2018-00083
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MWJ111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2018
• 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): Other