MAUDE Adverse Event Report: TORNIER S.A.S. AEQ REV II HEXAGONAL TIP AO DIA 2.5MM FOR SINGLE USE; BIT, DRILL

Catalog Number	DWD167
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/02/2024
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
It was reported that the hex screwdriver broke off when screwing the glenosphere.A piece of the tip got stuck in the glenosphere and could not be removed.Lege artis was used to complete the procedure.
Additional Manufacturer Narrative
Corrected field: d9 (product available to stryker).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.It states that: instruments which have experienced excessive use or excessive force are susceptible to breakage.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the hex screwdriver broke off when screwing the glenosphere.A piece of the tip got stuck in the glenosphere and could not be removed.Lege artis was used to complete the procedure.

• Brand Name: AEQ REV II HEXAGONAL TIP AO DIA 2.5MM FOR SINGLE USE
• Common Device Name: BIT, DRILL
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20528229
• Report Number: 3000931034-2024-00638
• Device Sequence Number: 9105627
• Product Code: HTW
• UDI-Device Identifier: 03700386943775
• UDI-Public: (01)03700386943775(11)240408(17)290408(10)5936AZ095
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: Health Professional
• Device Catalogue Number: DWD167
• Device Lot Number: 5936AZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2024
• 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
• Patient Sex: Unknown