MAUDE Adverse Event Report: STRYKER GMBH U-BLADE LAG SCREWDRIVER GAMMA3; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	13200310
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2025
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: "tip of lag screw driver broke off.Instrument rotated on lag screw.Screw was completely inserted into patient.Case type: pertrochanteric fracture".
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could be confirmed based on the provided pictures, as the tip of the instrument appears to be broken.However, without detailed pictures of the breakage surface as well as a proper device inspection, it is impossible to determine a root cause solely based on the provided pictures.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.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.It is worth noting the device was manufactured in 2017, approximately 8 years ago.Therefore, it cannot be excluded normal wear and tear may have contributed to the event.In this relation, the stryker instructions for cleaning, sterilization, inspection and maintenance provides information to identify when the device should no longer be reused or is still within specification.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "tip of lag screwdriver broke off.Instrument rotated on lag screw.Screw was completely inserted into patient.Case type: pertrochanteric fracture".

• Brand Name: U-BLADE LAG SCREWDRIVER GAMMA3
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22141609
• Report Number: 0008031020-2025-00937
• Device Sequence Number: 12581775
• Product Code: HSB
• UDI-Device Identifier: 04546540377845
• UDI-Public: (01)04546540377845(11)170327(10)K035E1B
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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: 13200310
• Device Lot Number: K035E1B
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2017
• 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