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	Foreign Body In Patient (2687)
Date of Event	07/22/2025
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, unfortunately, the guide pin (dwd063) was placed in the sharps bin and discarded as it was broken and sharp, risking injury if sent for sterilization.The majority of the wire came out with/inside the central peg drill (other two instruments listed in the email), once the surgeon had finished with that step of the operation.This was left until the end of the operation to take apart and it was presumed that the whole wire was inside the drill (as happens in other operations).It was only noticed that the tip of the guide wire was missing during closure of the patient, with the surgeon requesting an x-ray to confirm their suspicion, that the tip of the wire was still located in the scapula of the patient just behind the implant.No other medical intervention occurred.
Additional Manufacturer Narrative
Correction: b1 (product problem added along with adverse event) and d9 (product was not returned as initially expected).The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device 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.No indications of material, manufacturing or design related problems were found during the investigation.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 any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that, unfortunately, the guide pin (dwd063) was placed in the sharps bin and discarded as it was broken and sharp, risking injury if sent for sterilization.The majority of the wire came out with/inside the central peg drill (other two instruments listed in the email), once the surgeon had finished with that step of the operation.This was left until the end of the operation to take apart and it was presumed that the whole wire was inside the drill (as happens in other operations).It was only noticed that the tip of the guide wire was missing during closure of the patient, with the surgeon requesting an x-ray to confirm their suspicion, that the tip of the wire was still located in the scapula of the patient just behind the implant.No other medical intervention occurred.Additional information: the tip of the guide wire is still inside the patient looks to be encased in the scapula directly behind the glenoid implant (which is cemented in position).The rest of the wire was discarded as it was not viable for sterilization due to its sharp/broken condition.

• 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: 22835151
• Report Number: 3000931034-2025-00467
• Device Sequence Number: 8592750
• Product Code: HWE
• UDI-Device Identifier: 03700386931796
• UDI-Public: (01)03700386931796(11)241210(17)291210(21)5070BA020
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: Lay User/Patient
• Device Catalogue Number: DWD063
• Device Lot Number: 4996BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 11/12/2025
• 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 Sex: Unknown