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

Model Number	GLENOID BASEPLATE IMPACTOR
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3000931034-2021-00280
• Device Sequence Number: 14335041
• Product Code: HWA
• UDI-Device Identifier: 03700386968969
• UDI-Public: 03700386968969
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown