MAUDE Adverse Event Report: STRYKER GMBH T2 - NAIL HOLDING SCREW, TIBIA 10 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060370
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
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anesthetized, were found to be defective and unusable.Our agent had to urgently deliver another instrument, which was withdrawn in an emergency from one of our deposit accounts, causing considerable inconvenience to both customers and significantly lengthening the duration of the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." 5/27/2025 - upon product return, a second nail holding screw was returned.
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 nail holding screw (lot k953367) is highly worn out and partially deformed at the shaft section close to the threads.This is most likely due to repetitive friction, therefore causing local accumulation of material and thickening.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.A fully functional nail handle sample was then used.The deformed nail holding screw could not be inserted as previously.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.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.In addition, the deformation of the nail holding screw (lot k953367) caused its diameter to be larger, and therefore preventing it from being inserted even into a functional nail handle.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 handle, preventing the nail holding screw from being inserted.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." 5/27/2025 - upon product return, a second nail holding screw was returned.
Additional Manufacturer Narrative
Please refer to h6 (results code).

• Brand Name: T2 - NAIL HOLDING SCREW, TIBIA 10 MM
• 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; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22310767
• Report Number: 0008031020-2025-00993
• Device Sequence Number: 8081879
• Product Code: LXH
• UDI-Device Identifier: 04546540196484
• UDI-Public: 04546540196484
• 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): 09/04/2025

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: 18060370
• Device Lot Number: K175477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2010
• 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