MAUDE Adverse Event Report: STRYKER GMBH U-BLADE SET, TI GAMMA3® Ø10.5X80MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30660080S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Perforation (2001); Limb Fracture (4518); Implant Pain (4561)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a patient who had undergone internal fixation with a long gamma nail 3 years earlier had shown bony fusion, but when he/she felt pain and a femoral neck fracture and osteonecrosis were found.The lag screw had been penetrated to the pelvis, but because of his/her advanced age, the surgeon chose to have the replacement with only a bipolar.".
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.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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: "a patient who had undergone internal fixation with a long gamma nail 3 years earlier had shown bony fusion, but when he/she felt pain and a femoral neck fracture and osteonecrosis were found.The lag screw had been penetrated to the pelvis, but because of his/her advanced age, the surgeon chose to have the replacement with only a bipolar.".

• Brand Name: U-BLADE SET, TI GAMMA3® Ø10.5X80MM
• 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: 18917218
• Report Number: 0009610622-2024-00101
• Device Sequence Number: 17865726
• Product Code: HSB
• UDI-Device Identifier: 04546540595966
• UDI-Public: 04546540595966
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 30660080S
• Device Lot Number: K0C5D5F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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 Age: 85 YR
• Patient Sex: Female
• Patient Weight: 48 KG