MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31251180S

Device Problems Break (1069); Fracture (1260)

Patient Problems Injury (2348); No Information (3190)

Event Date 07/26/2019

Event Type  Injury  

Manufacturer Narrative

Device was not returned. If additional information becomes available, it will be provided in a supplemental report. Device disposition unknown.

Event Description

As reported: "on 2014 patient underwent surgery following a pertrochanteric fracture of the right femur. Due to pseudarthrosis of the fracture, the nail broke, was removed and a new synthesis was performed on (b)(6)2019. ".

Event Description

As reported: "on (b)(6) patient underwent surgery following a pertrochanteric fracture of the right femur. Due to pseudarthrosis of the fracture, the nail broke, was removed and a new synthesis was performed on (b)(6)2019. ".

Manufacturer Narrative

The reported event could be confirmed based on the review of the x-rays provided. A device inspection was not possible since the affected device was not returned. Medical review was performed and revealed the following: nail breakage is visible in the x-ray. The patient is 92 years old, osteoporotic/osteopenic bone is most likely to be there. Due to the missing images of the initial fracture patterns and results after the operation, the reason of failure cannot be determined. It appears to have been a reversed oblique fracture which is known to likely end up in pseudarthrosis. General aspects: the gamma3 nail is a temporary implant which inevitably will be subject of a fatigue fracture if the biomechanical stresses on the implant are too high or not considerably reduced during the period of implantation. During this period there is a race between bony consolidation / fracture healing and implant breakage as noted in the labelling of the product. Usually a breakage is contributed by one or more deficits, e. G. Insufficient bone healing, product damage. Generally, the risk of a breakage will increase with the increase of load cycles and load level. Nail breakage in general has been experienced but does not present an unanticipated event in itself. Depending on load application, also, depending on the patient¿s post implant behavior and depending on suitable anatomical reduction, depending on the kind of bone breakage, depending on the course of bone healing and other factors ¿ e. G. Increased post-operative activities ¿ a nail breakage can rather be classified as anticipated; specifically, if one or more contributing issues concurrence with each other. Based on the investigation performed, the event is not linked to a deficiency of a device. The exact root cause can not be determined due to the missing images of the initial fracture patterns and results after the operation. The ifu instructs user that: 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. As the device was broken after the 5 years. A review of the device history for the reported lot did not indicate any abnormalities. No corrective actions are required at this time. No indications of material, manufacturing or design related problems were found during the investigation. A review of the labeling did not indicate any abnormalities. If the device is returned or if any additional information is provided, the investigation will be reassessed. H3 other text : device retained by the hospital; x-rays provided.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM 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
• MDR Report Key: 8974119
• Report Number: 0009610622-2019-00639
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 31251180S
• Device Lot Number: K0DDBD7
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Age: 92 YR
• Patient Outcome(s): Required Intervention