MAUDE Adverse Event Report: STRYKER GMBH LAG SCREW, TI GAMMA3® Ø10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3060-0095S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Implant Pain (4561)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "cut-out of the femoral neck screw with the gamma nail lying on the right.Patient was in pain and underwent a revision surgery.".
Additional Manufacturer Narrative
Please note the corrections to b1 and d3.The reported event could be confirmed based on the evidence received.The x-ray inspection revealed the following, as stated by a medical expert: "to assess a cut-out with only one image is difficult, however, if material is out in one plane it is out.I would say, that the tip of the screw has crossed the femoral cortex and is now in direct contact to the subchondral bone of the acetabulum and that would be a cut-out.I would assume, that there is non-union at the fracture site.This led to some back-out of the screw, but additionally due to subsidence of the neck-head-fragment the tip of the screw migrated through the subchondral cortex of the femoral head.Without postoperative x-ray and the lateral view all of this is speculative and there is insufficient information." the post-operative behavior of the patient was not communicated and the time of implantation is unknown.Therefore, it was not possible to determine if the patient's activity may have also played a role on the implant cut-out.More x-rays would have been necessary for a more detailed view of the patients femur and a more precise investigation.Due to the lack further evidence, it was not possible to determine a clear root cause of the reported event.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "cut-out of the femoral neck screw with the gamma nail lying on the right.Patient was in pain and underwent a revision surgery.".

• Brand Name: LAG SCREW, 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17025955
• Report Number: 0009610622-2023-00182
• Device Sequence Number: 20708085
• Product Code: HSB
• UDI-Device Identifier: 04546540374936
• UDI-Public: 04546540374936
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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: 3060-0095S
• Device Catalogue Number: 30600095S
• Device Lot Number: K0EB161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• 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 Age: 86 YR
• Patient Sex: Female
• Patient Weight: 65 KG