MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported via the (b)(6) form that : "a (b)(6)-year-old patient had a left per-trochanteric fracture and had osteosynthesis of her fracture in (b)(6) [2018] by a gamma nail.She has been seen several times by her surgeon.X-rays in (b)(6) 2019 showed a small deformation of the nail.In (b)(6) 2019, she had a severe pain in her left hip with a deformity.X-rays show a fracture of the gamma nail with a displaced femur fracture.Patient's current condition: fracture of the left femur.Actions undertaken in the care facility for the care of the patient: removal of material with installation of a total hip prosthesis and a long tail femoral stem and osteosynthesis of the femur by strapping bands.Phone call with initial reporter: the patient (b)(6), female, (b)(6) kg, 1m60 was taken in charge by the [hospital] until (b)(6), they saw on the xrays in may that the nail was torn ((b)(6)), and then it broke ((b)(6)).The patient did feel pain in (b)(6) - explantation and then, beginning (b)(6) she is followed by [surgeon] at the [other hospital].

Manufacturer Narrative

The reported event could be confirmed.Although the device was not returned for evaluation, an x-ray was provided which confirms the failure; the x-ray was not sufficient for further medical assessment.More information such as pre and post-op x-rays and product must be available in order to determine the exact root cause.However, as described in the event that even after 10 months of implantation the fracture didn¿t heal and was further displaced, hence the most probable cause of failure would be breakage of nail due to non-union.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.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 is unknown.

Event Description

It was reported via the ansm form that : "a 90-year-old patient had a left per-trochanteric fracture and had osteosynthesis of her fracture in december [2018] by a gamma nail.She has been seen several times by her surgeon.X-rays in may 2019 showed a small deformation of the nail.In october 2019, she had a severe pain in her left hip with a deformity.X-rays show a fracture of the gamma nail with a displaced femur fracture.Patient's current condition: fracture of the left femur.Actions undertaken in the care facility for the care of the patient: removal of material with installation of a total hip prosthesis and a long tail femoral stem and osteosynthesis of the femur by strapping bands.Phone call with initial reporter: the patient mr, female, 44kg, 1m60 was taken in charge by the [hospital] until october, they saw on the xrays in may that the nail was torn (may), and then it broke (october).The patient did feel pain in october - explantation and then, beginning the 28 october she is followed by [surgeon] at the [other hospital].

• Brand Name: UNKNOWN GAMMA3 NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9513679
• MDR Text Key: 178380260
• Report Number: 0009610622-2019-00979
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 44