MAUDE Adverse Event Report: STRYKER GMBH U-BLADE SET, TI GAMMA3 Ø10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30660095S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "primary surgery with gamma3 nail and u-lag screw was performed on (b)(6) 2022.On (b)(6) 2025, when the patient visited the hospital with an irregular heartbeat, lag screw cut-out was observed.On (b)(6) 2025, the revision surgery was performed for removing u-lag screw.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was returned but medical records and the x-rays are needed in this case for event confirmation.The device inspection revealed the following: the u blade set was received, and one leg of the u blade is found deformed outwards.The over stretched leg of the u-blade gives the impression that it has not sit properly in the threaded groove of the lag screw but to confirm it absolutely that it happened during surgery, immediate post -operative x-ray is needed.Furthermore, the set screw impression for adequate fixation of the lag screw is missing in the lag screw groove, there is no indication that the set screw was tightened in the groove after the insertion.Although, there is an impression on the edge of the groove of the lag screw which shows that the set screw was most likely tightened at the edge of the groove and not at the bottom as required.This is also further confirmed by the impression on the tip of the set screw where there is a strong deformation at one side of the set screw while the top surface has no visible mark.We tried to assemble the returned set screw, nail and lag screw, and found that the set screw could be fixed in the groove of the lag screw.Also, the set screw leaves a mark of tightening in the groove.It was tried two times and on both occasions the set screw left an impression in the groove.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, it could not be excluded that the set screw was most likely tightened at the edge of the groove and not at the bottom as required as per operative technique which could lead to the loosening of the lag screw.But to confirm the event and other observations like deformation of u blade and explore probabilities of patient related or clinical factors , medical records such as x-rays are needed which are not available at this time.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "primary surgery with gamma3 nail and u-lag screw was performed on (b)(6) 2022.On (b)(6) 2025, when the patient visited the hospital with an irregular heartbeat, lag screw cut-out was observed.On (b)(6) 2025, the revision surgery was performed for removing u-lag screw.".

• Brand Name: U-BLADE SET, TI GAMMA3 Ø10.5X95MM
• 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: 21762669
• Report Number: 0009610622-2025-00010
• Device Sequence Number: 8490469
• Product Code: HSB
• UDI-Device Identifier: 04546540595997
• UDI-Public: (01)04546540595997(11)220214(17)270131(10)K0255B3
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 30660095S
• Device Lot Number: K02555B3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 58 KG