MAUDE Adverse Event Report: STRYKER GMBH T2 - NAIL HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18061002
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
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
As reported: "the instruments, once the patient had already been anesthetized, were found to be defective and unusable.Our agent had to urgently deliver another instrument, which was withdrawn in an emergency from one of our deposit accounts, causing considerable inconvenience to both customers and significantly lengthening the duration of the operation.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and could not be assembled properly.The device inspection revealed the following: the inner part of the nail handle is highly worn out, which led to local deformation from repetitive friction.Both nail holding screws (worn out one and intact one) could not be inserted through the nail handle as intended.They both jammed at the level of the observed inner deformation.The damages observed on the nail holding screw (lot k953367) and the inner nail handle were most likely mutually caused due to friction and forced assembly overtime.As a consequence, the nail holding screw (lot k175477) could not be inserted anymore in the deformed nail handle, despite being intact.The dimensional inspection confirmed the above.There is a local deformation inside the nail handle, reducing the inner diameter.Therefore, both nail holding screws cannot be inserted anymore.Based on investigation, the root cause was attributed to a user related issue.The devices were most likely not inspected and tested properly before the procedure, leading to unnoticed deformation due to wear on the nail holding screw and nail handle.As a reminder, the stryker instructions for cleaning, sterilization, inspection and maintenance help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.The instructions for use also state: « before every operation, ensure that all devices to be used during the operation function correctly with each other ».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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the instruments, once the patient had already been anesthetized, were found to be defective and unusable.Our agent had to urgently deliver another instrument, which was withdrawn in an emergency from one of our deposit accounts, causing considerable inconvenience to both customers and significantly lengthening the duration of the operation.".

• Brand Name: T2 - NAIL HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; postfach; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22064169
• Report Number: 0008031020-2025-00908
• Device Sequence Number: 8477815
• Product Code: LXH
• UDI-Device Identifier: 04546540196538
• UDI-Public: (01)04546540196538(10)K12763B
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: 18061002
• Device Lot Number: KHI022827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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