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

Model Number HEX 2.5MM

Device Problem Material Fragmentation (1261)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 03/21/2019

Event Type  Injury  

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 Description

Tip of the screwdriver broke while positioning the glenosphere.If broken part in the hole and in the patient is unknown.

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED SCREWDRIVER
• Type of Device: SCREWDRIVER HEXAGONAL TIP
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• Manufacturer Contact: maud andriollo ; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 8548916
• MDR Text Key: 143036687
• Report Number: 3000931034-2019-00059
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 03700386971006
• UDI-Public: 03700386971006
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Model Number: HEX 2.5MM
• Device Catalogue Number: MWB991
• Device Lot Number: 17C586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other