MAUDE Adverse Event Report: TORNIER S.A.S. OPEN END WRENCH 14MM

Model Number	UNKNOWN
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Component Missing (2306)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
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 during a surgery two references were missing from the kit, and it caused a delay on surgery.Due to the missing instruments mwd423 and mwd553, the final tightening screw for the implant was missing.This has led to consequential problems in the final implantation.
Additional Manufacturer Narrative
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.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material manufacturing related problems were unable to be identified as the lot number was not communicated.A labeling review was not deemed necessary for the reported event since the alleged issue is related to shipping and ordering problem not related to the intended use of the device.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.However, an nc was open locally to further investigate the issue.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that during a surgery two references were missing from the kit, and it caused a delay on surgery.Due to the missing instruments mwd423 and mwd553, the final tightening screw for the implant was missing.This has led to consequential problems in the final implantation.
Additional Manufacturer Narrative
Correction: please refer to section h6 device and health impact codes.
Event or Problem Description
It was reported that during a surgery two references were missing from the kit, and it caused a delay on surgery.Due to the missing instruments mwd423 and mwd553, the final tightening screw for the implant was missing.This has led to consequential problems in the final implantation.Additional information received: how was the surgery completed? with alternative and improvised solutions that involved using a non-specific insert impactor and tightening the stem with a strong clamp instead of the wrench.Was there any delay in the surgery? yes.20 minutes.

• Brand Name: OPEN END WRENCH 14MM
• Common Device Name: WRENCH
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21406889
• Report Number: 3000931034-2025-00063
• Device Sequence Number: 21161793
• Product Code: HXC
• UDI-Device Identifier: 03700386983214
• UDI-Public: 03700386983214
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 06/25/2025

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 Model Number: UNKNOWN
• Device Catalogue Number: MWD553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 04/11/2025; 05/27/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/08/2025; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown