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 Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/14/2021
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
On (b)(6) 2021, gamma 3 surgery was performed on the right proximal femur.On (b)(6) 2021, although the details of the breakage are unknown, the u-blade lag screw that was fixed to the gamma 3 nail was found to have failed and moved upward to the head of the bone.The u-lag portion of this lag screw was deformed so that it opened forward.The surgeon plans to collect the defective device when performing the girdle stone later.
Event or Problem Description
On (b)(6) 2021, gamma 3 surgery was performed on the right proximal femur.On (b)(6) 2021, although the details of the breakage are unknown, the u-blade lag screw that was fixed to the gamma 3 nail was found to have failed and moved upward to the head of the bone.The u-lag portion of this lag screw was deformed so that it opened forward.The surgeon plans to collect the defective device when performing the girdle stone later.
Additional Manufacturer Narrative
The reported event was confirmed on provided x-rays.The review of manufacturing documents revealed no deviation in the manufacturing process.Required material properties had been confirmed prior to manufacturing.No nc/capa had been filed for the item in question.Potential implant cut-out had been considered in the risk management file with appropriate values not having been exceeded by this case.The labelling already informs about that a temporary implant requires sufficient bone consolidation resp.Support in order to relieve the nail during the implantation period.The labelling points refers in detail to the procedure steps for u-blade lag screw treatment.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented a gamma3 u-blade set had protruded through the femur head after an implantation period of allegedly less than 7 weeks.The product was not available for investigation.Received medical documents (including x-rays) revealed the product-id.A medical statement was possible because a second view (in m-l-direction) was not available.Cut out is a typical complication of proximal femoral nailing.This harm does not primarily depend on the implant.It is mostly caused by the kind of fracture, patient's general condition and primarily the respective surgical technique.In this case the root cause was regarded as patient related.In case the item or further substantive information becomes available we reserve the right to reopen the investigation with new root cause assessment.

• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12579446
• Report Number: 0009610622-2021-00729
• Device Sequence Number: 11634811
• Product Code: HSB
• UDI-Device Identifier: 04546540595997
• UDI-Public: 04546540595997
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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: 09/30/2025
• Device Model Number: 3066-0095S
• Device Catalogue Number: 30660095S
• Device Lot Number: K086163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• 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: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian