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

Model Number 3125-1180S

Device Problem Fracture (1260)

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

Event Date 11/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision of broken gamma nail.Replacement with proximal femur plate depuy synthes.

Manufacturer Narrative

The reported event could be confirmed.The device inspection revealed the following: the breakage of the nail occurred because of the fatigue of the material.Indeed, the different surfaces on the bridges determined that the nail was subjected to a constant repetitive mechanical load (especially in torsion) for a while, until the material broke.The rest lines as well as the tension lines are clear indication of that.The mis-drilling traces that can be seen on the device could also have contributed in introducing weak points from which the cracks could either have started or had appeared after and propagated.The mis-drilling traces that can be seen on the device could also have contributed in introducing weak points from which the cracks could either have started or had appeared after and propagated.Since the x-rays were provided, the opinion of a medical expert was requested.They statement is as follows: "[.] the lagscrew is long.Unfortunately the length is not mentioned in the report.But it must be long, since the reduction is not done properly at all.The entry of the nail is not at the tip of the trochanter, but next to it in the fracture.So there is no reduction and by that way less stability of the fracture.This could have contributed to the failing of the nail.[.]" therefore, based on the information provided by the material analysis and the medical opinion, the root cause is determined to be user related.Indeed, an inadequate lag screw size selection could be considered the primary root cause for the breakage.Indeed, a lag screw which is too long introduced a bigger lever arm which results in forces that are larger than necessary on the device.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.If any further information is provided, the investigation report will be updated.

Event Description

Revision of broken gamma nail.Replacement with proximal femur plate depuysynthes.

• 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; DE D-24232
• MDR Report Key: 9532522
• MDR Text Key: 178642768
• Report Number: 0009610622-2019-01001
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: K077B78
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 89