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

Model Number	3066-0095S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem 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.".
Additional 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 or Problem 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
• 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: 14318034
• Report Number: 0009610622-2022-00171
• Device Sequence Number: 17448139
• Product Code: HSB
• UDI-Device Identifier: 04546540595997
• UDI-Public: 04546540595997
• 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
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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 Expiration Date: 07/31/2026
• 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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