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

Model Number 3066-0095S

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2022

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "gamma3 primary surgery was performed on february 18, 2022 without any problem.Approximately two months postoperatively, the u-lug screw penetrated the femoral head.Revision surgery with bipolar was performed on (b)(6) 2022.".

Manufacturer Narrative

The reported event could be confirmed.The device inspection revealed the following: the returned lag screw has implantation and explantation marks on its superior flute.These prominent marks may also be related to a post-operative dislocation of the lag screw, indicating that the set screw was not properly seated and locked.Based on investigation, the root cause was attributed to a user related issue along with secondary patient factor issues (low activity level, former smoker, heavy alcohol intake).The migration of the lag screw may be due to inadequate insertion of the set screw inside the nail, leading to inadequate fixation of the lag screw with the set screw and setting it free.As a reminder, the instructions for use state: ¿ during the course of the operation, repeatedly check to ensure that the connection between the implant and the instrument, or between the instruments, required for precise positioning and fixing is secure.Implants which consist of several components must only be used in the prescribed combination (see operative technique).¿ 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.If more information is provided, the case will be reassessed.

Event Description

As reported: "gamma3 primary surgery was performed on (b)(6) 2022without any problem.Approximately two months postoperatively, the u-lug screw penetrated the femoral head.Revision surgery with bipolar was performed on april 12, 2022.".

• Brand Name: U-BLADE SET, TI GAMMA3® Ø10.5X95MM
• 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
• 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: 14318034
• MDR Text Key: 291498631
• Report Number: 0009610622-2022-00171
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540595997
• UDI-Public: 04546540595997
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3066-0095S
• Device Catalogue Number: 30660095S
• Device Lot Number: K0D40BD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female