MAUDE Adverse Event Report: TORNIER S.A.S. MINI MAXLOCK EXTREME; HEXSTAR¿ TAPERED DRIVER - 2.4MM

Model Number DIAMETER 2.4 MM

Device Problem Material Fragmentation (1261)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.Though this device is not commercially available for sale in the us, it is similar to a device currently marketed for sale in the us.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.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

Event Description

During a revision surgery in ordert o remove an arthrodesis plate, the hexstar¿ driver broke at the tip.Additional surgery time (one hour).Using a saw to cut the plate.

Manufacturer Narrative

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

• Brand Name: MINI MAXLOCK EXTREME
• Type of Device: HEXSTAR¿ TAPERED DRIVER - 2.4MM
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: maud andriollo-sanchez ; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 8413191
• MDR Text Key: 138557894
• Report Number: 3000931034-2019-00036
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

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: Health Professional
• Device Model Number: DIAMETER 2.4 MM
• Device Catalogue Number: M-MXM056T
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other