MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED SLAPHAMMER FOR GLENOID SPHERE SIZE 36; EXTRACTOR

Catalog Number	MWB216
Medical Device Problem Codes	Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the surgeon couldn't explant the glenosphere.Patient had an infection.The surgery was initially prolonged for 30 minutes and eventually cancelled.
Event or Problem Description
It was reported that the surgeon couldn't explant the glenosphere.Patient had an infection.The surgery was initially prolonged for 30 minutes and eventually cancelled.
Additional Manufacturer Narrative
Corrected field: product available to stryker (d9).The reported event could not be confirmed since the device was not returned for evaluation and no other evidences 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.No indications of material manufacturing or design related problems were found during the investigation.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 in order 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.
Event or Problem Description
It was reported that the surgeon couldn't explant the glenosphere.Patient had an infection.The surgery was initially prolonged for 30 minutes and eventually cancelled.
Additional Manufacturer Narrative
Corrections: please refer to sections d9 the device was returned and h6 (method, results and conclusion codes).The reported event could be confirmed since the device was returned and was found to be in condition stated in the event description.A device inspection confirmed that the sphere extractor was significantly damaged at the threads.The device showed signs of extensive usage evident by the appearance of significant degraded surfaces (brown surfaces, scratches, tool marks, deformed edges).It was impossible to screw the screw into the sphere extractor due to the degraded state of each thread.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a user related issue.The event was caused by the long and repeated usage of the device after long periods of use (since 2010).Normal weakening of structural integrity contributed to the damage noted in this complaint.It is safe to say that it has performed its task in the former surgeries as intended till now, without any reported anomaly.If any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQUALIS REVERSED SLAPHAMMER FOR GLENOID SPHERE SIZE 36
• Common Device Name: EXTRACTOR
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21952270
• Report Number: 3000931034-2025-00234
• Device Sequence Number: 8382462
• Product Code: HWB
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MWB216
• Device Lot Number: 10B793
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 04/28/2026
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 07/08/2025; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2010
• 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