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

Model Number	DIAM. 2.5MM LENGTH 200 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem 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.
Additional 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
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 11377483
• Report Number: 3000931034-2021-00021
• Device Sequence Number: 4076673
• Product Code: HSD
• UDI-Device Identifier: 03700386931796
• UDI-Public: 03700386931796
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2025
• 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 Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other