MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II UNIVERSAL GLENOID BASEPLATE IMPACTOR

Model Number GLENOID BASEPLATE IMPACTOR

Device Problem Material Deformation (2976)

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

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Tightening bolt on inner rod had stripped threads.Making it impossible to assemble with impactor handle.Therefore making it impossible to attach the baseplate to the impactor.Surgeon tried to assemble the impactor with vise grips without success.No back-up device was available.The surgeon had to hold the baseplate tight with his fingers while hammering the impactor.This caused a 20 minute delay.

Manufacturer Narrative

Corrections: please refer to d9/h3 product available to stryker ; h4 manufacturing date ; h6 method code, results code, conclusion code, and health impact code.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device discarded.

Event Description

Tightening bolt on inner rod had stripped threads.Making it impossible to assemble with impactor handle.Therefore making it impossible to attach the baseplate to the impactor.Surgeon tried to assemble the impactor with vise grips without success.No back-up device was available.The surgeon had to hold the baseplate tight with his fingers while hammering the impactor.This caused a 20 minute delay.

• Brand Name: AEQUALIS REVERSED II UNIVERSAL GLENOID BASEPLATE IMPACTOR
• Type of Device: IMPACTOR
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 12004247
• MDR Text Key: 259603777
• Report Number: 3000931034-2021-00280
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 03700386968969
• UDI-Public: 03700386968969
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: GLENOID BASEPLATE IMPACTOR
• Device Catalogue Number: MWB138
• Device Lot Number: 10B803
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other