MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON Ø9X340 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18430934S
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has been returned and is being evaluated.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that patient's left femur was revised approximately 2 months post primary implant after patient twisted while unreeling a garden hose and broke the im nail approximately 1.5 inches proximal to the distal lag recon screw.Patient was revised to a competitor construct.
Additional Manufacturer Narrative
The reported event that reconstruction nail r1.5, ti, left t2 recon ø9x340 mm x 125° was alleged of issue k-170 (implant breakage - nail) could be confirmed, since the device was returned for evaluation and it matches the reported failure mode.A device inspection revealed the following: the received nail is completely broken in the webs of the lower proximal lag screw hole.All implants received show traces of use.The breakage surface of the anterior web of the nail have a smooth topography over the whole cross section, whereas the breakage surfaces of the posterior web show a rougher appearance, which reveals the breakage not running as consistently as through the anterior web.On all breakage surfaces of both anterior and posterior web, features of a fatigue fracture are visible.Plastic deformation was not found.According to the signs of damage and the evidences of the breakage surfaces the nail broke in a fatigue manner after an implantation period of approximately 2 months.As per the event description ¿patient's left femur was revised approximately 2 months post primary implant after patient twisted while unreeling a garden hose and broke the im nail.¿.One requirement for successful nail treatment is a timely bone healing in order to relieve the nail over the progressing time of implantation.The failure was caused due to patient twisting which might have caused significant load application on the implant which resulted in its breakage.Instructions regarding post-operative patient activities are clearly stated in the labelling.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.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.During this period there is a race between bony consolidation / fracture healing and implant breakage as noted in the labelling of the product.Usually a breakage is contributed by one or more deficits, e.G.Insufficient bone healing, product damage.Generally, the risk of a breakage will increase with the increase of load cycles and load level.Nail breakage in general has been experienced, but does not present an unanticipated event in itself.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.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that patient's left femur was revised approximately 2 months post primary implant after patient twisted while unreeling a garden hose and broke the im nail approximately 1.5 inches proximal to the distal lag recon screw.Patient was revised to a competitor construct.

• Brand Name: RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON Ø9X340 MM 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: 7654988
• Report Number: 0009610622-2018-00252
• Device Sequence Number: 19119169
• Product Code: HSB
• UDI-Device Identifier: 04546540383709
• UDI-Public: 04546540383709
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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 Catalogue Number: 18430934S
• Device Lot Number: K03C3D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 08/10/2018
• 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: 73 YR