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); Pain (1994); Non-union Bone Fracture (2369); Implant Pain (4561)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that : "patient operated for a pertrochanteric fracture of the right femur on (b)(6) 2020 in emergency.Poses nail range, simple suite, 3 months after the patient is taken back to the or due to the failure of the osteosynthesis material by right total hip revision prosthesis.Simple follow-up again with resumption of gait the gamma nail is ruptured at the junction with the cervical screw.[.] the broken part of the system is the "trochanteric nail".".

Event Description

The customer reported that : "patient operated for a pertrochanteric fracture of the right femur on (b)(6) 2020 in emergency.Poses nail range.Simple suite.3 months after the patient is taken back to the or due to the failure of the osteosynthesis material by right total hip revision prosthesis.Simple follow-up again with resumption of gait.The gamma nail is ruptured at the junction with the cervical screw.The broken part of the system is the "trochanteric nail".".

Manufacturer Narrative

The reported event could be confirmed with the help of x-rays and the report provided.The device inspection was not possible as the product was not returned for investigation.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.Formal medical opinion was sought from an experienced independent medical expert as below; ¿in the one provided image received this is difficult to assess, but there are two aspects that are remarkable.First: the reposition of the fracture is not perfect.A pretty big fracture line can be identified in the image.The other aspect is that the lag screw is positioned pretty eccentrical.From only one plane this cannot be assessed completely, but it looks, as if the screw is positioned caudally.It appears as if it is positioned anteriorly as well, but that could only be said together with the other plane.Potentially, the age may have contributed to a poor fracture healing.Beside the fracture pattern with the basicervical fracture line which is sometimes challenging, the poor fracture reduction and the eccentrical position of the lag screw may have contributed to a delayed resp.Non-union with the consequent device failure.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿the implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.Regular post-operative examinations (e.G.X-ray checks) are advisable.¿ based on investigation, the root cause was primarily attributed to a user related issue i.E.Poor fracture reduction along with the patient factor i.E.Poor healing due to age.Medical expert opinion also states ¿the poor fracture reduction and the eccentrical position of the lag screw may have contributed to a delayed resp.Non-union with the consequent device failure.¿ if device is returned or any further information is provided, the investigation report will be reassessed.

• 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: 11345204
• MDR Text Key: 232444863
• Report Number: 0009610622-2021-00281
• 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: 06/16/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 3125-1180S
• Device Catalogue Number: 31251180S
• Device Lot Number: K05055D
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 64