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

Catalog Number 31251180S

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The following event was reported to the sales rep: " gamma 3 nail broken under the cervical screw.Fall of the patient who bumped into the door of her terrace.".

Manufacturer Narrative

The reported event could be confirmed since the device was returned and matches the alleged failure mode.The device inspection revealed the following: the received nail is completely broken in the webs of the proximal drill hole for the lag screw.On all breakage surfaces of both left and right web features of a fatigue fracture are visible (evident by the presence of lines of rest).Plastic deformation was not found.Areas with signs of friction / seizing [bearing points of lag screw] are visible at both medial and lateral edge of the proximal part.Similar areas were identified at the distal medial edge.The countermarks were found on the lag screw in the areas with corresponding friction signs and worn edges due to poor positioning of lag screw.Based on review of the x-rays that were provided, as well as other patient information, the root cause was attributed to a user-patient related issue.The failure was caused by poor positioning and consequent instability of the lag screw leading to additional stress on the nail as evident by the bearing marks.This additional stress caused weakening of nail and ultimately initiated a fracture in a fatigue manner.When the patient fell, it finally broke the nail completely.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 any further information is provided, the complaint report will be updated.

Event Description

The following event was reported to the sales rep: " gamma 3 nail broken under the cervical screw.Fall of the patient who bumped into the door of her terrace.".

Event Description

The following event was reported to the sales rep: "gamma 3 nail broken under the cervical screw.Fall of the patient who bumped into the door of her terrace.".

Manufacturer Narrative

The reported event could be confirmed based on the review of the x-rays provided.Based on review of the x-rays that were provided, as well as other patient information, the root cause was attributed to a user/patient related issue.The failure was caused by fall of the patient who bumped into the door of her terrace, as reported, and wrong positioning of the cervical screw.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 disposition unknown.

• 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: 8621422
• MDR Text Key: 145472954
• Report Number: 0009610622-2019-00251
• 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,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 31251180S
• Device Lot Number: K020D79
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention