MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X260MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-0260S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported, subtrochanteric fracture of the femur on (b)(6) 2019.The long gamma nail was used.On (b)(6) 2020, the nail was broken starting from the nail lag screw insertion hole.Tha scheduled for revision.
Additional Manufacturer Narrative
The reported event could be confirmed, since provided x-ray images confirmed the reported nail breakage.A device inspection was not possible since the affected device was not returned.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.According to event description a revision was scheduled to revise the affected nail by a tha which would indicate that an adequate fracture healing is no longer be expected after an implantation period of approximately 4 months.Due to further details provided ¿the removal operation was already over.It seems difficult to recover the broken implant.¿ 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.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.H3 other text : device disposition is unknown.
Event or Problem Description
It was reported, subtrochanteric fracture of the femur on (b)(6) 2019.The long gamma nail was used.On (b)(6) 2020, the nail was broken starting from the nail lag screw insertion hole.Tha scheduled for revision.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X260MM X 125
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 10076710
• Report Number: 0009610622-2020-00253
• Device Sequence Number: 3218279
• Product Code: HSB
• UDI-Device Identifier: 04546540375698
• UDI-Public: 04546540375698
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: 04/30/2024
• Device Model Number: 3525-0260S
• Device Catalogue Number: 35250260S
• Device Lot Number: K05A0D1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR