MAUDE Adverse Event Report: STRYKER GMBH U-BLADE SET, TI GAMMA3 Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30660090S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: postoperatively, a cutout occurred requiring revision surgery.
Additional Manufacturer Narrative
Corrections to b1.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.In the case presented a female patient (b)(6) year old had been treated with above u-lag screw on (b)(6) 2024.The patient allegedly experienced a cut out and was revised with a tha [total hip arthroplasty] on (b)(6) 2024.Based on the information available, no product deficiency has been identified.Contraindications, warnings and precautions as well as possible adverse effects are indicated in the instructions for use.The rmf considers that a revision surgery due to cut out or medialization is a typical complication of proximal femoral nailing.This damage is not primarily dependent on the implant.It is usually caused by the type of fracture, the general condition of the patient [osteoporosis] and primarily by the respective surgical technique.In the event of a severing, there would be extensive damage to the hip joint, which would have to be treated with an endoprosthesis.Due to a lack of medical information, no x-ray image was provided; it was not possible to determine whether the event was actually a medialization or rather a lag screw cut out.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.A cut out, collapse of femur head over the lag screw, is attributed to a patient related issue.
Event or Problem Description
As reported: postoperatively, a cutout occurred requiring revision surgery.

• Brand Name: U-BLADE SET, TI GAMMA3 Ø10.5X90MM
• 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: 20092438
• Report Number: 0009610622-2024-00821
• Device Sequence Number: 12684651
• Product Code: HSB
• UDI-Device Identifier: 04546540595980
• UDI-Public: (01)04546540595980(17)280731(10)K16B986
• 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
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 30660090S
• Device Lot Number: K16B986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2023
• 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: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female