MAUDE Adverse Event Report: STRYKER GMBH T2 - LOCKING SCREW, FULLY THREADED D4X30MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18964030S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "a radiolucent drill broke, and a spare drill was used to resolve the issue.The screw could not be inserted into the hole of the nail.".
Event or Problem Description
As reported: "a radiolucent drill broke, and a spare drill was used to resolve the issue.The screw could not be inserted into the hole of the nail.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.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.The operative technique states that: ¿after drilling both cortices with the calibrated 3.5×230mm drill (1806-3540s), the screw length may be read directly off of the calibrated drill at the end of the drill sleeve.¿ [original statements].No indications of material, manufacturing or design related problems were found during the investigation.Based on the provided information, the radiolucent drill was used which broke during surgery but optech specified the appropriate drill to be used.Use of a radiolucent drill can be termed as off-label use.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.If the device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: T2 - LOCKING SCREW, FULLY THREADED D4X30MM
• 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: 23204154
• Report Number: 0008031020-2025-01657
• Device Sequence Number: 21116963
• Product Code: HSB
• UDI-Device Identifier: 04546540202345
• UDI-Public: (01)04546540202345(17)291231(10)K0FDA80
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• 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): 11/19/2025

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: 18964030S
• Device Lot Number: K0FDA80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• 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