MAUDE Adverse Event Report: STRYKER GMBH U-BLADE SET, TI GAMMA3® Ø10.5X85MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30660085S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2024
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.H3 other text : device remains implanted in the patient.
Event or Problem Description
Orif was performed for left intertrochanteric femoral fracture of a 88 years old female patient on (b)(6), 2024.The x-ray image taken one month postoperative follow-up revealed a metal fragment like object that was not seen immediately after the surgery while the patient has no complaint.The doctor provided the x-ray images and requests stryker to identify if it was an implant part.
Additional Manufacturer Narrative
The received x-rays were reviewed, it can be confirmed that there is a fragment next to the u-blade visible.There is no indication that the fragment belongs to the implants, the size is too small to be a sub-component of the implants and the fragment has a special shape, similar to a clamping piece, which speaks against a fragment that broke off from the implants.However, without having the physical devices back for evaluation no clear conclusion is possible and the root cause can not be defined.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.More detailed information about the complaint event as well as the affected devices must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
Orif was performed for left intertrochanteric femoral fracture of a 88 years old female patient on (b)(6) 2024.The x-ray image taken one month postoperative follow-up revealed a metal fragment like object that was not seen immediately after the surgery while the patient has no complaint.The doctor provided the x-ray images and requests stryker to identify if it was an implant part.

• Brand Name: U-BLADE SET, TI GAMMA3® Ø10.5X85MM
• 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: 18948224
• Report Number: 0009610622-2024-00105
• Device Sequence Number: 7965564
• Product Code: HSB
• UDI-Device Identifier: 04546540595973
• UDI-Public: 04546540595973
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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 Catalogue Number: 30660085S
• Device Lot Number: K16B982
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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: Other
• Patient Age: 88 YR
• Patient Sex: Female