MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, RIGHT T2 GTN 10X360 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1851-1036S

Device Problem Fracture (1260)

Patient Problems Fall (1848); Failure of Implant (1924); Limb Fracture (4518)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

"it was reported via medwatch # (b)(4): "on (b)(6) 2020, patient sustained injury while playing on monkey bars at school.Fell sustaining a per-prosthetic right proximal femur fracture.Fracture was immediately distal to the retained femoral plate.Patient brought to the operating room the next day and underwent removal of blade plate implant and screws, right proximal femur and open reduction of right proximal femur fracture with insertion of intramedullary nail with proximal and distal locking screws.Discharged next day.Patient doing well until one month later.Patient was shooting baskets at school when he felt a pop in his right leg and immediately fell and had significant pain.X-rays showed fractured intramedullary nail through the distal of the 2 proximal locking screw holes.The rod broke in that position, but the bone gave way through the previous area of fracture.After a plan was made to remove the broken femoral nail and then treat the fracture with a standard adult blade plate and appropriate implants and equipment were obtained, patient was brought to the operating room to undergo removal of the broken implant and fixation of his right proximal femur fracture with a fixed angle blade plate.Patient did well and returned to recovery in stable condition.Remains inpatient without incident." additionally reported: "patient does have developmental dysplasia of the hip and type i diabetes, along with charcot-marie-tooth.".

Event Description

"it was reported via medwatch #(b)(4): "on (b)(6) 2020, patient sustained injury while playing on monkey bars at school.Fell sustaining a per-prosthetic right proximal femur fracture.Fracture was immediately distal to the retained femoral plate.Patient brought to the operating room the next day and underwent removal of blade plate implant and screws, right proximal femur and open reduction of right proximal femur fracture with insertion of intramedullary nail with proximal and distal locking screws.Discharged next day.Patient doing well until one month later.Patient was shooting baskets at school when he felt a pop in his right leg and immediately fell and had significant pain.X-rays showed fractured intramedullary nail through the distal of the 2 proximal locking screw holes.The rod broke in that position, but the bone gave way through the previous area of fracture.After a plan was made to remove the broken femoral nail and then treat the fracture with a standard adult blade plate and appropriate implants and equipment were obtained, patient was brought to the operating room to undergo removal of the broken implant and fixation of his right proximal femur fracture with a fixed angle blade plate.Patient did well and returned to recovery in stable condition.Remains inpatient without incident.".Additionally reported: "patient does have developmental dysplasia of the hip and type i diabetes, along with charcot-marie-tooth.".

Manufacturer Narrative

The reported event could be confirmed, since physical evaluation revealed a broken nail.The implant was completely broken in the webs of the most distal of the proximal bore ones.A detailed visual inspection of the proximal part revealed a notch at the posterior lateral edge of the proximal bore.The breakage line and residual fracture shows signs of torsional stress and bending load and beyond that the breakage surfaces of both webs presents signs of a fatigue fracture.Although x-ray images and medical reports were requested but without success we received following additional patient details, ¿patient does have developmental dysplasia of the hip and type i diabetes, along with charcot-marie-tooth¿, which were forwarded for a clinical statement by a hcp [excerpts]: ¿¿difficult to assess without an x-ray.Obviously, there had already been an implant failure with a plate.Then the nail was inserted.The boy is 12 has hip dysplasia, diabetes and hereditary neurosensory neuropathy.This results in muscle atrophy and ataxia, which of course can lead to a higher load on the implant.Obviously, full loading was also done.Presumably, all of this with the signs of damage at the implant verified has led to implant failure.This of course remains all conjecture without an x-ray¿¿.What behaviors were advised by the physician for the postoperative period to the patient and whether or not the patient was compliant is unknown.However, according to the reported event, a full load apparently took place again relatively promptly ¿¿patient doing well until one month later.Patient was shooting baskets at school when he felt a pop in his right leg¿¿.Based on details provided it could not be excluded that patient conditions in conjunction with pre-damage of the implant, which is confirmed by signs of damage verified at the most distal of the proximal bore ones, led to the implant failure after an implantation period of approximately one month.Thus, it has to be classified as patient related due to patient conditions and contributed by a pre-damaged implant.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.

• Brand Name: FEMORAL NAIL, RIGHT T2 GTN 10X360 MM
• 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: 11076840
• MDR Text Key: 223772928
• Report Number: 0009610622-2020-01060
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540647474
• UDI-Public: 04546540647474
• Combination Product (y/n): N
• PMA/PMN Number: K101438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Model Number: 1851-1036S
• Device Catalogue Number: 18511036S
• Device Lot Number: K092880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Weight: 55