MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED STERILE PIN; BIT, DRILL

Model Number	200 MM
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
During drilling the glenoid center hole, the tip of guide pin broke off in the glenoid bone.The surgeon was only able to retrieve a piece of the broken pieces (the tip of the pin had been broken into two pieces.) about 1cm-length piece remained in the patient.The retrieved portion of the pin has been blackened and it was not certain if the cannulated drill bit had problems.It will be returned for analysis as well.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED STERILE PIN
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 7112196
• Report Number: 3000931034-2017-00210
• Device Sequence Number: 19187946
• Product Code: HTW
• UDI-Device Identifier: 03700386931796
• UDI-Public: 03700386931796
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 12/31/2021
• Device Model Number: 200 MM
• Device Catalogue Number: DWD063
• Device Lot Number: 6995AR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 05/14/2018
• 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
• Patient Age: 66 YR
• Patient Weight: 84