MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS PERFORM GLENOID GRASPER; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number MWE114

Device Problems Residue After Decontamination (2325); Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The glenoid grasper had cement on the part that holds the implant.Surgery continued and the surgeon did not use the instrument.No backup set was available.Surgeon inserted the implant manually to the glenoid.At the end of the case surgeon doubled the antibiotic dose.

Manufacturer Narrative

This is the final 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.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: AEQUALIS PERFORM GLENOID GRASPER
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 10913705
• MDR Text Key: 219144243
• Report Number: 3000931034-2020-00152
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 03700386973598
• UDI-Public: 03700386973598
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

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 Catalogue Number: MWE114
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/27/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other