MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3125-1180S

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Injury (2348); Implant Pain (4561)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

The customer has reported the following event: "we would like to report an incident that occurred on (b)(6) 2020 with a gamma nail (trochanteric nail 11x180mm x125°).An (b)(6) year old patient (female) operated on (b)(6) 2019 for a left femur nail, and is taken back to the block on (b)(6) 2020 for an ablation of the material because the nail is broken and installation of an intermediate hip prosthesis.".

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.The quality certificate of the heat number was reviewed.It corresponds to the material defined on the drawing and to the internal material specification.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: "informing the patient the implantation affects the patient¿s ability to carry loads and her/his mobility and general living circumstances.For this reason, the surgeon must counsel each patient individually on correct behavior and activity after the implantation.The surgeon must warn the patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future.Explain the need to report unusual changes in the implantation area as well as falls or accidents even if the device or the site of operation did not appear to be harmed at the time.¿ more detailed information about the complaint event (such as x-rays) as well as the affected device must be available in order to determine the root cause of the complaint event.However, in general one of the probable causes of nail breakages is patient related such as non-compliant behavior of patient after implantation.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

The customer has reported the following event: "we would like to report an incident that occurred on (b)(6) 2020 with a gamma nail (trochanteric nail 11x180mm x125°).An 89 year old patient (female) operated on (b)(6) 2019 for a left femur nail, and is taken back to the block on (b)(6) 2020 for an ablation of the material because the nail is broken and installation of an intermediate hip prosthesis.".

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10451919
• MDR Text Key: 204358196
• Report Number: 0009610622-2020-00488
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375070
• UDI-Public: 04546540375070
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3125-1180S
• Device Catalogue Number: 31251180S
• Device Lot Number: K099110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR