MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED SCREWDRIVER; SCREWDRIVER HEXAGONAL TIP

Model Number	HEX 2.5MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/05/2017
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
Hexagonal tip broke inside the glenosphere.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED SCREWDRIVER
• Common Device Name: SCREWDRIVER HEXAGONAL TIP
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 8424697
• Report Number: 3000931034-2019-00045
• Device Sequence Number: 11208855
• Product Code: HXX
• UDI-Device Identifier: 03700386971006
• UDI-Public: 03700386971006
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

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: No Information
• Device Model Number: HEX 2.5MM
• Device Catalogue Number: MWB991
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 09/06/2019
• 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