MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3 10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3066-0090S

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Injury (2348); Ambulation Difficulties (2544)

Event Date 07/08/2020

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

As reported: left femoral trochanteric fracture.On (b)(6) 2019 gamma3 surgery.She recovered steadily after surgery, but suddenly she was unable to walk.The lag screw was cut out when the x-ray was taken.(b)(6) 2020 revision plan to change to bipolar.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences 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.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 if any additional information is provided, the investigation will be reassessed.

Event Description

As reported: left femoral trochanteric fracture.(b)(6) 2019.Gamma3 surgery.She recovered steadily after surgery, but suddenly she was unable to walk.The lag screw was cut out when the x-ray was taken.(b)(6) 2020 revision plan to change to bipolar.

• Brand Name: U-BLADE SET, TI GAMMA3 10.5X90MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10379929
• MDR Text Key: 202180162
• Report Number: 0009610622-2020-00441
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540595980
• UDI-Public: 04546540595980
• Combination Product (y/n): N
• PMA/PMN Number: K043431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3066-0090S
• Device Catalogue Number: 30660090S
• Device Lot Number: K076B61
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 40