MAUDE Adverse Event Report: TORNIER S.A.S. AEQ GLENOID AND REVSD PIN-DO NOTT IMPLANT DIA 3MM LENGTH 170MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY

Catalog Number	DWD063
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the guide wire was broken upon drilling it in patient.The additional medical intervention was needed with the usage of broken screw set and xray.Later, the x-ray showed nothing was left in patient.The longer anesthesia and operating time was also reported.No further information was provided.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed.The device was not returned but evidence was provided, which match the alleged failure.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.From the only provided picture taken just after the device explantation (soiled instrument), we can observe that, the pin is broken at the thread in the almost full drilled position and the broken tip was extracted from the patient.No additional information could be observed.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.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that, the guide wire was broken upon drilling it in patient.The additional medical intervention was needed with the usage of broken screw set and xray.Later, the x-ray showed nothing was left in patient.The longer anesthesia and operating time was also reported.No further information was provided.

• Brand Name: AEQ GLENOID AND REVSD PIN-DO NOTT IMPLANT DIA 3MM LENGTH 170MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY
• 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: 23154830
• Report Number: 3000931034-2025-00519
• Device Sequence Number: 5178531
• Product Code: HWE
• UDI-Device Identifier: 03700386931796
• UDI-Public: (01)03700386931796(11)241210(17)291210
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: Lay User/Patient
• Device Catalogue Number: DWD063
• Device Lot Number: 4988BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female