MAUDE Adverse Event Report: STRYKER GMBH IMN SCREWS - ADVANCED LOCKING SCREW D5X35MM; SCREW, FIXATION, BONE

Catalog Number	23615035S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
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: "while inserting an advanced locking screw into the proximal screw hole, the screw became stuck and was extracted with the screwdriver sleeve.The screw was able to be extracted but was stuck in the screwdriver sleeve.Another screw was inserted and the procedure was successfully completed.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the was stuck on the instrument as described in the event description.The device inspection revealed the following: the screwdriver sleeve and the advanced locking screw were returned in assembled condition.The advanced locking screw is strongly damaged, the thread flanks are especially at the crossover of the shaft threads totally flattened, but also the rest of the threads is in a bad condition, only the thread at the head is just slightly damaged as it was protected by the sleeve.The hexagon in the screw head is actually no longer present, as it is completely worn away.At all damages is the anodized layer no present anymore, which shows that they were caused post-manufacturing.The threads of the sleeve are slightly damaged, which can be traced back to normal wear and tear over the years.The damage has no influence on the functionality of the device.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 visible damages at the hexagon recess and the threads of the screw indicates that there was an excessive contact between the screw and the nail during the insertion attempt, this contact did finally also lead to the jamming between the screw and the sleeve.In this relation following statement of the t2 alpha femur retrograde nailing system operative technique (t2-st-53, rev 1, 09-2022) can be pointed out: ¿the advanced locking screw must be inserted using reasonable force to provide desired function and to avoid damaging the screw.If unreasonable insertion torque is noticed, stop insertion, turn the screw counterclockwise and then attempt to insert the screw.If unreasonable insertion torque is still noticed, remove the screw and proceed with a locking screw.¿ if more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "while inserting an advanced locking screw into the proximal screw hole, the screw became stuck and was extracted with the screwdriver sleeve.The screw was able to be extracted but was stuck in the screwdriver sleeve.Another screw was inserted and the procedure was successfully completed.".

• Brand Name: IMN SCREWS - ADVANCED LOCKING SCREW D5X35MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 23316937
• Report Number: 0008031020-2025-01934
• Device Sequence Number: 5827026
• Product Code: HWC
• UDI-Device Identifier: 07613327381597
• UDI-Public: (01)07613327381597(17)340930(10)K1E0905
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: 23615035S
• Device Lot Number: K1E0905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 72 KG