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

Catalog Number	MWE114
Medical Device Problem Codes	Residue After Decontamination (2325); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
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
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.
Additional 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
• Common Device Name: 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
• Report Number: 3000931034-2020-00152
• Device Sequence Number: 11343472
• Product Code: HTD
• UDI-Device Identifier: 03700386973598
• UDI-Public: 03700386973598
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: MWE114
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/27/2020
• Supplement Report FDA Received Date: 01/27/2021
• 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