MAUDE Adverse Event Report: STRYKER GMBH IMN SCREWS - ADVANCED LOCKING SCREW D5X55MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23615055S
Medical Device Problem Codes	Positioning Failure (1158); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
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: "when inserting the distal advance locking screw, the distal targeting device was loose, and the screw was driven in at an incorrect angle beyond the acceptable insertion range.As a result, the screw became stuck with the nail and could not be removed.Although it was eventually extracted with effort, the products were damaged." on 11/06/2025 - additional information received: how was the issue solved? longer screwdriver was used as an alternative.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The received short screwdriver sleeve was firmly stuck to the screw.There are visible deformation marks on the proximal gripping section, likely resulting from the application of excessive force during disassembly.Furthermore, the screw head exhibits significant thread deformation.The thread crests appear flattened and show a shiny surface, indicating material displacement and rubbing, which suggests misalignment during assembly or removal combined with high force application.Functional inspection was not feasible as the screw head is completely stuck inside the sleeve.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 the above investigation, the issue is deemed to be user related, as damage on the screw head indicate that the screw was inserted in misaligned manner.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "when inserting the distal advance locking screw, the distal targeting device was loose, and the screw was driven in at an incorrect angle beyond the acceptable insertion range.As a result, the screw became stuck with the nail and could not be removed.Although it was eventually extracted with effort, the products were damaged." 11/06/2025 - additional information received: how was the issue solved? longer screw driver was used as an alternative.

• Brand Name: IMN SCREWS - ADVANCED LOCKING SCREW D5X55MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 23632952
• Report Number: 0008031020-2025-02094
• Device Sequence Number: 9317438
• Product Code: HSB
• UDI-Device Identifier: 07613327381610
• UDI-Public: (01)07613327381610(17)350228(10)K115DF0
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K251400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 23615055S
• Device Lot Number: K115DF0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2025
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 80 KG