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	03/21/2019
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
Tip of the screwdriver broke while positioning the glenosphere.If broken part in the hole and in the patient is unknown.
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: 8548916
• Report Number: 3000931034-2019-00059
• Device Sequence Number: 2443318
• 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): 03/27/2019

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
• Device Lot Number: 17C586
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/25/2019
• 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