MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS GLENOID & REVERSED PIN; SHOULDER JOINT METAL PROSTHESIS

Model Number DIAM. 2.5MM LENGTH 200 MM

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The guide wire was advanced into the glenoid, the surgeon wanted to adjust the pin location and backed out the pin.The distal tip of the dwd063 guide wire broke off right at the start of the threads.The piece that broke off was left in the scapula and could not be retrieved.

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 malfunction or is related to a death or injury.

• Brand Name: AEQUALIS GLENOID & REVERSED PIN
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 11377483
• MDR Text Key: 234977756
• Report Number: 3000931034-2021-00021
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03700386931796
• UDI-Public: 03700386931796
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

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 Model Number: DIAM. 2.5MM LENGTH 200 MM
• Device Catalogue Number: DWD063
• Device Lot Number: 8530AV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other