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

Catalog Number 41251180S

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The clinic reported to the ansm the following event : " in post-operative rehabilitation for a pertrochanteric fracture of the right femur, she was walking on her walker when she had severe pain, with a perceived cracking in her right femur.Left hip (hip operated on in (b)(6) 2018 for fracture of the upper end of the left femur with gamma/chg perpignan nail)¿¿.Patient's current condition: the radiographical balance sheet confirms a fracture of the material on the left handle.Actions undertaken in the facility for patient care: re-hospitalization for new intervention on the left handley for cloud ablation and position of an intermediate prosthesis with synthesis of the great trochanter by haubanage.Patient still in the hospital to this day.Conservation of the material for expertise.

Manufacturer Narrative

The reported event that trochanteric nail kit, stst gamma3® ø11x180mm x 125° was alleged of issue - implant breakage ¿ nail) could be confirmed, since the device was returned for evaluation and it matches the reported failure mode.The evaluation revealed that the nail broke in a fatigue fracture after a period of approx.6 months of implantation.According to found damages the fatigue fracture had its origination in the web at lateral.In this area material damage had weakened the web caused by misaligned drilling with the step drill; which presents an unintentional use error.General aspects: a nail will be subject of a fatigue fracture if the stresses on the implant are too high or not considerably reduced during the period of implantation.The affected implant is designed to withstand the normal loads during the implantation period, i.E.The implant must neither be exposed to peak loads nor to continuous stresses.Another prerequisite for a successful supply is undisturbed, normal bone healing.This state must be achieved within a medically recognized period (confirmed by scientific analysis about 6 months) in such way, that the bone strength allows significantly increasing discharge of the time-fixed implant material.In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications.A review of the labeling did not indicate any abnormalities.The instruction for use conveys that most frequent adverse effects involving the use of internal fracture fixation devices are: ¿these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.Conditions attributable to non-union, osteoporosis, osteomalicia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ based on investigation, the root cause was attributed to user related issue.The failure was caused by misaligned drilling with the step drill affecting the strength of the implant.If any further information is provided, the complaint report will be updated.

Event Description

The clinic reported to the ansm the following event : " in post-operative rehabilitation for a pertrochanteric fracture of the right femur, she was walking on her walker when she had severe pain, with a perceived cracking in her right femur.Left hip (hip operated on in (b)(6) 2018 for fracture of the upper end of the left femur with gamma/chg perpignan nail)¿¿.Patient's current condition: the radiographical balance sheet confirms a fracture of the material on the left handle.Actions undertaken in the facility for patient care: re-hospitalization for new intervention on the left handley for cloud ablation and position of an intermediate prosthesis with synthesis of the great trochanter by haubanage.Patient still in the hospital to this day.Conservation of the material for expertise.

• Brand Name: TROCHANTERIC NAIL KIT, STST 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: 8162194
• MDR Text Key: 130311692
• Report Number: 0009610622-2018-01508
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K043431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 41251180S
• Device Lot Number: KU92876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention