MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA 9X315 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1822-0931S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the patient's left tibia was revised due to a broken tibial t2 nail and non-union.Surgeon reported that the patient tried to weight bear less than 2 months post-op.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the received nail is completely broken in the webs of one of the distal screw holes.One of the web¿s fractured surface shows shiny appearance (plastic deformation) which is a direct result of one part rubbing over another.This basically indicates towards a fatigue fracture where one part on one side separated first, gradually and due to loading it continued to rub with the separated surface before the other web on the other side broke too.The holes at the distal end of the nail also exhibit slight deformation and marks, which is usually a sign of increased loading and excessive screw movement.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The x-rays provided were presented to our hcp.Evaluation was done strictly based on the available x-rays in the provided views and on the given patient details.Original condition of the patient, other critical parameters and operative notes were unavailable at the time of evaluation: ¿looking at image 1 and 2 it is a fracture which could be treated with a nail.It must be taken into account that both the tibia and fibula are broken and that the fracture is quite low.However, with proper reduction and post-operative care it would be a genuine possibility.I am not sure when image 3 and 4 are taken, if that is the post-operative result, it is not acceptable at all in both directions.There is no reduction, it is even worse than the preoperative x-rays.With this alignment the fracture will most probably not heal.Image 5-6 show the consequences of the poor reduction.If this patient was allowed to walk on this fracture in this state, it is not strange that the nail breaks, but it would probably have broken anyway, since a non-union was probably the only possible outcome for this reduction.¿ based on the above investigation, the root cause of the failure is both user and patient related, but predominantly user related.There is clearly a non-union, which as per clinical assessment was attributed to a rather inadequate fracture reduction.Hence, due to which an increased loading on the nail lead to its breakage in a fatigue manner.The ifu clearly specifies: ¿¿ 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.¿ if any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the patient's left tibia was revised due to a broken tibial t2 nail and non-union.Surgeon reported that the patient tried to weight bear less than 2 months post-op.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA 9X315 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10476965
• Report Number: 0009610622-2020-00492
• Device Sequence Number: 3119577
• Product Code: HSB
• UDI-Device Identifier: 04546540197764
• UDI-Public: 04546540197764
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: 05/31/2023
• Device Model Number: 1822-0931S
• Device Catalogue Number: 18220931S
• Device Lot Number: K074A39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 11/04/2020
• 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: 56 YR
• Patient Weight: 59