MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X360MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	32300360S
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.
Event or Problem Description
The patient fell on (b)(6) 2017 and contracted a proximal femur fracture.On (b)(6) 2017, the operative restoration was performed using a proximal femoral nail.Initial regular course.At the clinical radiological check on (b)(6) 2018, the implant was intact with a partially consolidated fracture.Since mid-(b)(6) 2018 increased pain.The external radiograph revealed a nail fracture.At the performance in (b)(6), the patient was pain-compensated.Because of the further compensated situation and the restrained attitude of the patient towards surgery, no revision has been performed so far and the implant is still in situ.
Additional Manufacturer Narrative
The reported event that long nail kit r2.0, ti, right gamma3® ø11x360mm x 130° was alleged of issue k-170 (implant breakage - nail) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.As the product was not returned, it could not be determined in what way the nail had broken nor if the nail had been damaged intra-operatively.The gamma nail is designed for implantation until the bone consolidation occurs.Therefore, if no bone consolidation occurs or if consolidation is not sufficient, the system may break.The aim of post-operative care must be to ensure the promotion of bone consolidation.The gamma nail is not intended for full weight bearing in patients with complex unstable fractures until sufficient bone consolidation is confirmed in the follow-up x-rays.General aspects from technical point of view: 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.Material damage, even if unintentional, will reduce the implant¿s durability in such a way that a breakage must be expected.Depending on load application, also, depending on the patient¿s post implant behavior and depending on suitable anatomical reduction, depending on the kind of bone breakage, depending on the course of bone healing and other factors ¿ e.G.Increased post-operative activities - a nail breakage can rather be classified as anticipated ¿ specifically if one or more contributing issues concurrence with each other.Based on investigation, the root cause was attributed to patient related issue.The failure was most likely caused by mechanical overstressing, inadequate load or support which lead to implant failure.With available information a deficiency of the device was not verified.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.
Event or Problem Description
The patient fell on (b)(6) 2017 and contracted a proximal femur fracture.On (b)(6) 2017, the operative restoration was performed using a proximal femoral nail.Initial regular course.At the clinical radiological check on (b)(6) 2018, the implant was intact with a partially consolidated fracture.Since (b)(6) 2018 increased pain.The external radiograph revealed a nail fracture.At the performance in august, the patient was pain-compensated.Because of the further compensated situation and the restrained attitude of the patient towards surgery, no revision has been performed so far and the implant is still in situ.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X360MM X 130°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8367221
• Report Number: 0009610622-2019-00080
• Device Sequence Number: 19337328
• Product Code: HSB
• UDI-Device Identifier: 07613153313021
• UDI-Public: 07613153313021
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 32300360S
• Device Lot Number: K089A9D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other