MAUDE Adverse Event Report: TORNIER S.A.S. ORTHOPEDIC MANUAL SURGICAL INSTRUMENT; AEQUALIS REVERSED STERILE PIN KIT 200MM

Model Number	200MM
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial 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 or Problem Description
It was reported that a guide pin broke during the case.The pin was being placed to ream the glenoid for a perform implant when the threaded tip of the wire broke off inside the glenoid.The break caused a major delay in the case as the surgeon was trying to remove the tip.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Common Device Name: AEQUALIS REVERSED STERILE PIN KIT 200MM
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 6181242
• Report Number: 3000931034-2016-00232
• Device Sequence Number: 185212
• Product Code: HTW
• UDI-Device Identifier: 03700386931796
• UDI-Public: 03700386931796
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 200MM
• Device Catalogue Number: DWD063
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2016
• Supplement Date Received by Manufacturer: 11/16/2016
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 01/03/2018
• 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