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

Catalog Number	18060370
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2025
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: "t2 tibia nail holder bolt ref 18060370 that no longer fits in the t2 tibia nail holder ref 18061002.".
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "t2 tibia nail holder bolt ref (b)(4) that no longer fits in the t2 tibia nail holder ref (b)(4).".
Event or Problem Description
As reported: "t2 tibia nail holder bolt ref 18060370 that no longer fits in the t2 tibia nail holder ref 18061002.".
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was returned and h6 (method, results and conclusion code).The reported event could be confirmed based on the returned devices inspection.The device inspection revealed the following: the nail holding screw 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 nail holding screw could not be inserted through the nail handle as intended.They jammed at the level of the observed deformations.Then, a fully functional nail handle was used.The returned nail holding screw could not be inserted in the sample nail handle.The dimensional inspection confirmed the above observations.There is a local deformation on the nail holding screw (larger diameter than expected) as well as inside the nail handle (smaller diameter than expected).Therefore, the nail holding screw cannot be inserted anymore.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.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 from repetitive friction 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.If more information is provided, the case will be reassessed.

• Brand Name: NAIL HOLDING SCREW, TIBIA T2 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: 22011737
• Report Number: 0008031020-2025-00887
• Device Sequence Number: 5342644
• Product Code: LXH
• UDI-Device Identifier: 04546540196484
• UDI-Public: (01)04546540196484(10)K1A316C
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2025

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: KSS2300XL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 11/06/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/11/2025; 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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