MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø13X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34253360S
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted and is currently not available to be return.If additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
It was reported that the gamma nail in the patient's right femur has broken.Location of implant breakage unknown at time of report, but surgeon reported from a previous revision that patient has a history of osteoporosis.Patient is scheduled for revision at the end of (b)(6).
Additional Manufacturer Narrative
The reported event that long nail kit r1.5, ti, right gamma3® ø13x360mm x 125° was alleged of issue implant nail breakage could be confirmed, since the x-rays were returned for evaluation and matches with the reported event.A device inspection was not possible since the affected device was not returned.But evaluation of pre & post failure x-rays, confirmed the post-operative breakage of the nail.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.The instructions for use instructs user that ¿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.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.But based on the event description and patient history, possible causes could be attributed to patient related issues, as patient has history of osteoporosis, also patient was moderately active during post-operative time, which may have affected the fatigue strength of the device causing breakage.In general, 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.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the gamma nail in the patient's right femur has broken.Location of implant breakage unknown at time of report, but surgeon reported from a previous revision that patient has a history of osteoporosis.Patient is scheduled for revision at the end of december.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø13X360MM X 125°
• 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: 8207884
• Report Number: 0009610622-2019-00001
• Device Sequence Number: 211600
• Product Code: HSB
• UDI-Device Identifier: 04546540406668
• UDI-Public: 04546540406668
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 34253360S
• Device Lot Number: K01A6B7
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/21/2019
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 91