MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3066-0090S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
As reported: the u-lag screw cutout was occurred.The u-blade has deformed.Revision surgery to bipolar will be planned.
Event or Problem Description
As reported: the u-lag screw cutout was occurred.The u-blade has deformed.Revision surgery to bipolar will be planned.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were 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.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented a patient (no data provided) had been treated with above u-lag screw on (b)(6) 2022.The patient allegedly experienced a cut out and was revised with a bipolar hip on (b)(6) 2023.With available information a product deficiency was not determined.Contraindications, warnings and precautions and potential adverse effects are pointed out in the ifu: the rmf considers that a revision surgery due to cut out or medialization is a typical complication of proximal femoral nailing.This harm does not primly depend on the implant.It is mostly caused by the kind of fracture, patient's general condition (osteoporosis), and primly the respective surgical technique.In the case of a cut out an extensive damage of the hip joint would result which has to be treated with arthroplasty.Due to missing medical information ¿ no x-ray provided¿ it could not be determined whether the event actually presented a medialization or rather a cut-out of the lag screw.If more information or the item itself is provided, the case will be reassessed.A cut out, collapse of femur head over the lag screw, is attributed to a patient related issue.

• Brand Name: U-BLADE SET, TI GAMMA3® Ø10.5X90MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16718156
• Report Number: 0009610622-2023-00113
• Device Sequence Number: 7237772
• Product Code: HSB
• UDI-Device Identifier: 04546540595980
• UDI-Public: 04546540595980
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 3066-0090S
• Device Catalogue Number: 30660090S
• Device Lot Number: K075D30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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: Unknown