MAUDE Adverse Event Report: STRYKER GMBH IMN SCREWS - ADVANCED LOCKING SCREW D5X60MM; SCREW, FIXATION, BONE

Catalog Number	23615060S
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	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the hexagonal head of the advanced locking screw was missing so that the driver could not be used.The surgeon used another advanced locking screw and finished operation.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the screw has missing features as described in the event description.The device inspection revealed the following.The advanced locking screw was returned together with the original cardboard box.The visual inspection has shown that the hexagon recess is missing as complained, in addition it was detected that the left-hand thread at the head is missing too.The visible damages, scratches, were very likely caused by unsuccessful attempts to use the screwdriver.A review of the device history for the reported lot did not indicate any abnormalities.The lot in question was manufactured in february 2025 with a lot size of (b)(4) pieces and we are not aware of any other complaint of the same nature for the reported lot number.There is at this point no indication that other devices are also affected by the same occurrence.Based on investigation, the root cause was attributed to a manufacturing related issue.The evaluation has shown that the hexagon recess and the head thread are missing at the returned advanced locking screw as not all steps were carried out as required during the manufacturing process on this individual screw.A nc (non-conformity) was opened at the manufacturing site to address this event.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the hexagonal head of the advanced locking screw was missing so that the driver could not be used.The surgeon used another advanced locking screw and finished operation.".

• Brand Name: IMN SCREWS - ADVANCED LOCKING SCREW D5X60MM
• 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: 23318635
• Report Number: 0008031020-2025-01946
• Device Sequence Number: 4838574
• Product Code: HWC
• UDI-Device Identifier: 07613327381542
• UDI-Public: (01)07613327381542(17)350131(10)K1048C0
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 23615060S
• Device Lot Number: K1048C0
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2025
• 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 Sex: Unknown